DePuy Orthopaedics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1077-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

Product Classification:

Class II

Date Initiated: December 9, 2013

Date Posted: March 5, 2014

Recall Number: Z-1077-2014

Event ID: 67159

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.

Status: Terminated

Product Quantity: 2

Code Information:

Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)

Distribution Pattern:

Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated