Biomet Screw Instrument Tray 6 — Class II medical device recall Z-2363-2020
Terminated recall by Biomet, reported 2020-06-24, distributed nationwide. Device and tray that houses the device did not pass steam sterilization process validation testing
| Recall number | Z-2363-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Miami, FL, United States |
| Recall initiated | 2020-05-01 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-07-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CL, CN, CR, NL |
| Quantity | 705 units |
Product
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Reason for recall
Device and tray that houses the device did not pass steam sterilization process validation testing
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-2363-2020. 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.