PFC SIGMA Cruciate Retaining — Class II medical device recall Z-1077-2014
Terminated recall by DePuy Orthopaedics, Inc., reported 2014-03-05, distributed in CA, FL, IA, KY. Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky
| Recall number | Z-1077-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-12-09 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-06-10 |
| Distributed | CA, FL, IA, KY |
| Countries outside the US | CZ, DE, FI, SE |
| Quantity | 2 |
| Reason classes | potency, device malfunction |
| Lot numbers | 7806929, 7806934, 7810268 |
| Model numbers | 960015 |
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Reason for recall
Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.
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-1077-2014. 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.