Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Wars
FDA device recall Z-2091-2012 · posted 2012-07-27 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
- Action taken
- Zimmer sent an Urgent Medical Device Recall letter dated April 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Requests for alternative instruments should be requested by calling (574) 372-4470. Fax Back Inventory Return Certification Form is to be sent back to Zimmer at (574) 372-4265. All recalled instruments available at the distributor are to be returned to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. The Distributor notice included instructions to notify surgeons immediately of the recall and requested a list of hospitals and surgeons receiving the device be sent back to Zimmer via E-mail. Zimmer is continuing distribution of the replacement jaw ( 005901-026-40) until alternative tools are available. The distributors are asked to identify and deliver preferred alternative instruments to affected accounts. Beginning May 7, 2012 Urgent Recall notices are being sent to hospitals and surgeons identified with instructions to acknowledge the recall communication. For questions regarding this recall call 574-372-4807.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 1662 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
- Date initiated
- 2012-04-30
- Date posted
- 2012-07-27
- Date terminated
- 2014-06-04
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K031061) | Zimmer, Inc. | 2003-10-09 |