Recall Z-0062-2013 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer, Inc.
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
| Date | Oct 15, 2012 (initiated Sep 13, 2012) |
| Status | Terminated |
| Reason | Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue. |
| Root cause | Packaging change control |
| Action | Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice. |
| Quantity | 59 both lots |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960658 | COLLARLESS POLISHED TAPER HIP PROSTHESIS Zimmer, Inc., Jul 16, 1996 |