Recall Z-1699-2009 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Inc.
Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catatog Number: 00801102001. Total joint arthroplasty to control, restrict, or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plu
| 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 | 133 |
| Distribution | Worldwide Distribution -- United States, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001733 | ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES Zimmer, Inc., Jun 20, 2000 |