DePuy Orthopaedics, Inc. Recall: PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devic
DePuy Orthopaedics, Inc. Recall: PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devic is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DePuy Orthopaedics, Inc.; Product: PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthropl
| Recalling firm | DePuy Orthopaedics, Inc. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic. |
| Recall initiated | 20131209 |
| Recall number | Z-1077-2014 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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