Device Recall DePuy CEMENT RESTRICTOR, Size 5 의 리콜

Recall

57900

Class 2

Z-1688-2011

2011-01-27

2011-03-17

Terminated

United States

2013-04-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97711

The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. non-sterile product and/or contaminat.

DePuy Orthopaedics sent an URGENT INFORMATION  RECALL NOTICE dated January 27, 2011, to DePuy Area Directors, FMDs, Distributors, and Office Managers. The notice identified the product, the problem, and the action to be taken. All territories were required to ensure that all recalled products that remain in customer accounts and field inventory are returned immediately to Warsaw to the attention of Returns. Hospitals that purchased and potentially implanted the now recalled product should be provided appropriate notification of the recall and should complete and return a signed Reconciliation Form(s) within seven business days. If the hospitals have any inventory on hand that is subject to the recall, distributors should remove it or help the hospitals return it for credit. All Reconciliation Forms should be faxed to 574-372-7567. For questions regarding this recall call 574-372-7333.