Rappel de Device Recall PFC Sigma Round Dome Patella

Recall

59238

Class 2

Z-3099-2011

2011-06-28

2011-08-30

Terminated

United States

2013-08-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101933

Depuy initiated a voluntary recall effective immediately, for one lot of p.F.C. sigma rd dome patella 3 peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. in the recalled lot, the packaging is labeled for a p.F.C. sigma 38mm 3 peg round dome patella, but the product enclosed in the package is a p.F.C. sigma 35mm 3 peg oval dome patella.

The firm, Depuy , sent an email that included a letter entitled "URGENT INFORMATION - RECALL NOTICE" dated June 28, 2011 to DePuy Area customers ( Directors, Distributors, Office Managers, Hospital Representatives, and Doctors). The letter described the product, problem and actions to be taken. The letter also included implications of implanting the recalled device and patient communication information. The customers were instructed to immediately cease further implantation/use or distribution of the product, immediately return any recalled devices in their inventory, notify their customer of the recall and complete, sign and return the Reconciliation Form(s) via fax to DePuy at 574-372-7567 within seven business days. The letter also states that DePuy is not recommending prophylactic revision or additional follow up in the absence of symptoms. Additionally, DePuy recommends that surgeons continue to follow patients as per their standard care. Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's Scientific Information Office at 1-888-554-2482.