Recall Z-1686-2011 ยท JDK Prosthesis, Hip, Cement Restrictor
Depuy Orthopaedics, Inc.
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.
| Date | Mar 17, 2011 (initiated Jan 27, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Employee error |
| Action | 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 Reconciliat |
| Quantity | 20 |
| Distribution | Nationwide distribution including the states of MA, PA, FL, LA, MN, WA, WI, CO, GA, NY, NC and SC and the countries of Canada, Colombia, Ireland and Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800894 | DUPUY CEMENT RESTRICTOR TRIALS & INSTR. Depuy, Inc., May 2, 1980 |