Recall Z-1477-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture
| Date | Jun 26, 2009 (initiated Apr 29, 2009) |
| Status | Terminated |
| Reason | The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray. |
| Root cause | Employee error |
| Action | Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131. |
| Quantity | 14 |
| Distribution | Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070214 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM Zimmer, Inc., Mar 16, 2007 |