Recall Z-1077-2014— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1077-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-09

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2013-12-09, terminated 2014-06-10. It names one FDA 510(k) clearance: K943462. Product: PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.. Reason: 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..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Terminated: 2014-06-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K943462 — DARWIN KNEE SYSTEMJohnson & Johnson Professionals, Inc.·cleared 1994-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.