Custom Cancellous Thread — Class II medical device recall Z-0621-2021
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-0621-2021 |
|---|---|
| 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 | 427670, 534760, 534800 |
| Model numbers | CP161941, CP161943 |
Product
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.
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-0621-2021. 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.