Biomet 3i Dental Implant — Class II medical device recall Z-1961-2013
Terminated recall by Biomet 3i, LLC, reported 2013-08-21, distributed in MA. A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label corr
| Recall number | Z-1961-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet 3i, LLC, Palm Beach Gardens, FL, United States |
| Recall initiated | 2013-05-10 |
| Classified | 2013-08-13 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-08-13 |
| Distributed | MA |
| Countries outside the US | AU, BE, CH, DE, DK, ES, FR, IT, LU, SE |
| Quantity | 33 |
| Reason classes | labeling |
| Lot numbers | 2012101530, 2017/12 |
| Model numbers | BNSS513 |
Product
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Reason for recall
A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1961-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.