Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PFC SIGMA Cruciate Retaining (CR) Recalled by DePuy Orthopaedics, Inc. Due to Knee implant femoral devices were found to have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Quantity: 2
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, FL, IA, KY
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report