6 — Class II medical device recall Z-0618-2021
Terminated recall by Biomet, Inc., reported 2020-12-23, distributed nationwide. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packa
| Recall number | Z-0618-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-11-25 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CR, HK, IN, JP, KR, MY, NZ, SG, TW |
| Quantity | 7,428 |
| Reason classes | sterility, packaging |
| Lot numbers | 167600, 179750, 179940, 179960, 179980, 180020, 180660, 285790, 285800, 286450, 288750, 288790, 288880, 288890, 368030 |
| Model numbers | 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 |
Product
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
Reason for recall
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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-0618-2021. 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.