Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
Recall
- Recall Number
- Z-0253-2010
- Event Number
- 53399
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 8, 2009
- Posted
- November 13, 2009
- Terminated
- May 16, 2011
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
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.
Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
26,404 of all products