Safety
Nobel Biocare recall records (FDA)
FDA's public recall database lists 76 records with Nobel Biocare as the recalling firm; 74 are completed and 2 are open.1
How to read this list
- A recall means a company corrected or removed specific products; FDA classifies and tracks it.2
- "Terminated" means FDA considers the recall completed.2
- Most records concern specific references or lots. Your implant passport shows your lot numbers.
2 open records (as of our check): both concern Nobel Biocare N1™ TiUltra TCC products, one for a possible burr on the co-packed OsseoShaper™ instrument (2022) and one for a packaging pin that could breach the sterile barrier (2025).1
All records
| Recall | Started | Status | Product (as listed by FDA) | Reason given |
|---|---|---|---|---|
| Z-1101-2025 | 10 Jan 2025 | Open | . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Bioca… | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product. |
| Z-1565-2022 | 25 Jul 2022 | Open | Nobel Biocare N1 TiUltra TCC NP 3.5x13mm | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
| Z-0658-2022 | 17 Dec 2021 | Terminated | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a resul… |
| Z-1677-2021 | 29 Mar 2021 | Terminated | NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic … | Not manufactured to specification |
| Z-1678-2021 | 29 Mar 2021 | Terminated | NPr FCZImp Crwn ASC CC RP CAD 1-25s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic d… | Not manufactured to specification |
| Z-1679-2021 | 29 Mar 2021 | Terminated | NPr FCZImp Crwn ASC CC NP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic … | Not manufactured to specification |
| Z-1680-2021 | 29 Mar 2021 | Terminated | NPr FCZImp Crwn ASC CC RP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic … | Not manufactured to specification |
| Z-1681-2021 | 29 Mar 2021 | Terminated | NPr FCZImp Crwn ASC CC NP CAD 1-25 s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic … | Not manufactured to specification |
| Z-2828-2020 | 20 Jul 2020 | Terminated | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ja… | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second su… |
| Z-1851-2020 | 28 Aug 2019 | Terminated | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Produ… | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the… |
| Z-1852-2020 | 9 Aug 2019 | Terminated | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 3666… | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightene… |
| Z-1853-2020 | 9 Aug 2019 | Terminated | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - … | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightene… |
| Z-1854-2020 | 9 Aug 2019 | Terminated | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Pro… | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightene… |
| Z-1855-2020 | 9 Aug 2019 | Terminated | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - … | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightene… |
| Z-1856-2020 | 9 Aug 2019 | Terminated | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-un… | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment sho… |
| Z-1857-2020 | 9 Aug 2019 | Terminated | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog… | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightene… |
| Z-2207-2020 | 19 Jul 2019 | Terminated | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 | The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm).… |
| Z-2250-2020 | 28 May 2019 | Terminated | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended … | Packaged dental implant healing abutments were found to contain the wrong size device. |
| Z-1302-2020 | 14 Mar 2019 | Terminated | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1303-2020 | 14 Mar 2019 | Terminated | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1304-2020 | 14 Mar 2019 | Terminated | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepari… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1305-2020 | 14 Mar 2019 | Terminated | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing oste… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1306-2020 | 14 Mar 2019 | Terminated | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1307-2020 | 14 Mar 2019 | Terminated | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1308-2020 | 14 Mar 2019 | Terminated | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1309-2020 | 14 Mar 2019 | Terminated | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1310-2020 | 14 Mar 2019 | Terminated | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparin… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1311-2020 | 14 Mar 2019 | Terminated | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1312-2020 | 14 Mar 2019 | Terminated | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy … | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1313-2020 | 14 Mar 2019 | Terminated | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1314-2020 | 14 Mar 2019 | Terminated | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteoto… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1315-2020 | 14 Mar 2019 | Terminated | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1316-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has be… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1317-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has b… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1318-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. … | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1319-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has b… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1320-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection ha… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1321-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1322-2020 | 14 Mar 2019 | Terminated | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw i… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1323-2020 | 14 Mar 2019 | Terminated | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended us… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1324-2020 | 14 Mar 2019 | Terminated | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific inte… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-1325-2020 | 14 Mar 2019 | Terminated | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment scre… | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile durin… |
| Z-2529-2018 | 16 Mar 2018 | Terminated | Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower ja… | The product label has missing information, such as the lot number and expiration date, as well as other information. |
| Z-2375-2016 | 20 Jul 2016 | Terminated | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connec… | Incorrect drill protocol in the Instructions for Use (IFU) |
| Z-2237-2016 | 22 Jun 2016 | Terminated | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to b… | Incorrect top label on an implant package. |
| Z-2074-2015 | 22 Jun 2015 | Terminated | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was ass… | One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. |
| Z-1414-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1415-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1416-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1417-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1418-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1419-2015 | 9 Mar 2015 | Terminated | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1420-2015 | 9 Mar 2015 | Terminated | NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to b… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1421-2015 | 9 Mar 2015 | Terminated | NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be … | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1422-2015 | 9 Mar 2015 | Terminated | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be s… | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1423-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to … | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1424-2015 | 9 Mar 2015 | Terminated | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1425-2015 | 9 Mar 2015 | Terminated | NobelReplace CC NP 3.5x10mm, Article No. 36700. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1426-2015 | 9 Mar 2015 | Terminated | NobelReplace CC NP 3.5x11.5mm, Article No. 36701. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1427-2015 | 9 Mar 2015 | Terminated | NobelReplace CC NP 3.5x13mm, Article No. 36702. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1428-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 4.3x8mm, Article No. 36704. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1429-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 4.3x10mm, Article No. 36705. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1430-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 4.3x11.5mm, Article No. 36707. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1431-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 4.3x13mm, Article No. 36708. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.. |
| Z-1432-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 5.0x8mm, Article No. 36710. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1433-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 5.0x10mm, Article No. 36711. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1434-2015 | 9 Mar 2015 | Terminated | NobelReplace CC RP 5.0x13mm, Article No. 36713. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1435-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1436-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1437-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1438-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1439-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-1440-2015 | 9 Mar 2015 | Terminated | NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Z-0273-2014 | 24 Oct 2013 | Terminated | Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseoc… | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. |
| Z-2240-2008 | 2 Nov 2007 | Terminated | NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of t… | This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the i… |
| Z-0575-03 | 27 Jan 2003 | Terminated | Nobel Biocare Replace Select Radiographic Template, part number 30159. | Misprinted radiographic template plates. Misprinted labeling. |
76 record(s) from the openFDA recall database (recalling firm "Nobel Biocare"), retrieved 28 Sep 2026. "Terminated" means FDA considers the recall completed.
Worried?
Do not remove or ignore anything yourself. Ask your treating clinic to check your implant passport against the notice. You can also request an assessment or a second opinion.
Last updated 28 Sep 2026.
Sources
- Regulatory recordopenFDA device recall database — records with recalling firm "Nobel Biocare" (76 records) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.
- Regulatory recordMedical Device Recalls — what FDA recall classes and statuses mean — U.S. Food and Drug Administration, 2026-09-28. Accessed 28 Sep 2026.
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