Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS… — Class II medical device recall Z-2546-2014
Terminated recall by Zimmer, Inc., reported 2014-09-03. Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations
| Recall number | Z-2546-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-07-22 |
| Classified | 2014-08-26 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-09-15 |
| Quantity | 972,125 units |
| Reason classes | sterility, packaging |
| Model numbers | 00579104100, 00579104200, 00598304048, 00598304148 |
Product
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Reason for recall
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
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-2546-2014. 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.