PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Reported: March 5, 2014 Initiated: December 9, 2013 #Z-1077-2014
Product Description
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 2
- Distribution
- Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 2.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1077-2014.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11