All instrumentation associated with the Prelude PF Resurfacing Knee… — Class II medical device recall Z-1318-2016
Terminated recall by Biomet, Inc., reported 2016-04-13, distributed in CA, CO, GA, IN, KS, MI, MO, NC…. Inadequate design control.
| Recall number | Z-1318-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-03-09 |
| Classified | 2016-04-04 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-05-23 |
| Distributed | CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN, TX |
| Quantity | 576 |
Product
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Reason for recall
Inadequate design control.
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-1318-2016. 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.