Recall Z-0871-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity an
| Date | Jan 9, 2009 (initiated Nov 25, 2008) |
| Status | Terminated |
| Reason | Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured. |
| Root cause | Packaging process control |
| Action | Zimmer distributors were notified by email of letter dated 11/25/08 on 11/25/08. This letter is entitled "URGENT: DEVICE RECALL." Secondary consignees/user accounts were notified by a copy of the 11/25/08 letter, which was sent on or before 12/05/08. Consignees were instructed to stop using the product and to return it to Zimmer. For further information, please contact Zimmer, Inc. by telephone by dialing 800-613-6131. |
| Quantity | 10 |
| Distribution | Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023528 | NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerplus Orthopedics, Inc., Jan 17, 2003 |