ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene — Class II medical device recall Z-0359-2021
Terminated recall by Zimmer Biomet, Inc., reported 2020-11-11, distributed nationwide. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the
| Recall number | Z-0359-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-09-24 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2022-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 412 units |
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-26
Reason for recall
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
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-0359-2021. 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.