Z-1077-2014 Class II Terminated
FDA device recall Z-1077-2014 was initiated by DePuy Orthopaedics, Inc. on Dec 9, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 10, 2014). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 5, 2014
- Initiation Date
- Dec 9, 2013
- Termination Date
- Jun 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
Code Information
Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1077-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026