Contra-Angle Torque Driver Kit For Certain Internal Connection… — Class II medical device recall Z-1170-2014
Terminated recall by Biomet 3i, LLC, reported 2014-03-19, distributed nationwide. During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility
| Recall number | Z-1170-2014 |
|---|---|
| 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 | 2013-07-22 |
| Classified | 2014-03-11 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, CA, CN, CR, DE, DO, ES, FR, GB, HK, HU, IL, JP, KR, MX, PL, PT, PY, SE, SG, TW, UY |
| Quantity | 250 |
| Reason classes | sterility |
Product
Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason for recall
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
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-1170-2014. 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.