Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer,
FDA device recall Z-0871-2009 · posted 2009-01-09 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 10
- Distribution
- Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
- Date initiated
- 2008-11-25
- Date posted
- 2009-01-09
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE (K023528) | Centerplus Orthopedics, Inc. | 2003-01-17 |