Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices 의 리콜

Recall

67159

Class 2

Z-1077-2014

2013-12-09

2014-02-24

Terminated

United States

2014-06-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124799

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.

The recall is extended to the DePuy Distributor, Hospital, and Surgeon levels. The two affected distributors were contacted by telephone. Written communication to the two hospitals and one surgeon who received the devices will be delivered by DePuy Orthopaedics, Inc. via email or regular mail. The one affected surgeon will also be contacted by telephone by the Medical Safety Officer and a metallurgist, who will discuss the surgeon communication with the surgeon. The sales representatives aid customers in the affected device returns, as needed. The devices will be returned through the normal DePuy Returns process, to attention of Returns and marking H13-30C on the outside of the box. All (21) remaining devices have been verified as being returned and in quarantine. Effectiveness will be determined by product reconciliation, receipt of all hospital reconciliation forms, and receipt of international declaration from the International Affiliate. DePuy will follow-up with the affected hospitals until all hospital reconciliation forms are returned, and DePuy will follow-up with the International Affiliate until all international actions are complete and the international declaration is completed and return.