Recall Z-1616-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02. Orthopedic implant used in total hip arthroplasty.
| Date | Jul 27, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility. |
| Root cause | Packaging process control |
| Action | Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131. |
| Quantity | 147 of both products |
| Distribution | Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030724 | ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM Zimmer, Inc., Jun 3, 2003 |