Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM he
FDA device recall Z-0255-2010 · posted 2009-11-13 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Action taken
- 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 field correction please contact Zimmer, Inc. at 1-800-613-6131.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 26,404 of all products
- Distribution
- Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
- Date initiated
- 2009-10-08
- Date posted
- 2009-11-13
- Date terminated
- 2011-05-16
- 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 |
|---|---|---|
| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K070214) | Zimmer, Inc. | 2007-03-16 |