Recall Z-0853-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
| Date | Dec 23, 2014 (initiated Dec 4, 2014) |
| Status | Terminated |
| Reason | The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi |
| Root cause | Process design |
| Action | Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755 |
| Quantity | 83 units |
| Distribution | Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc., Mar 27, 2012 |