Recall Z-0254-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5428-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
| Date | Nov 13, 2009 (initiated Oct 8, 2009) |
| Status | Terminated |
| Reason | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. |
| Root cause | Other |
| Action | An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the |
| Quantity | 26,404 of all products |
| Distribution | Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain 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 |