Recall Z-1700-2009 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Inc.
Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint arthroplasy to control, restrict or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Imtramedullary canal must be plugged.
| Date | Jul 23, 2009 (initiated Jun 8, 2009) |
| Status | Terminated |
| Reason | The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility. |
| Root cause | Packaging process control |
| Action | Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974. |
| Quantity | 110 |
| Distribution | Worldwide Distribution -- United States, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040389 | COONRAD/MORREY ELBOW CEMENT RESTRICTOR Zimmer, Inc., May 17, 2004 |