Retiro De Equipo (Recall) de NEXGEN Complete Knee Solution Femoral and Accessory tool

Recall

61764

Class 2

Z-2091-2012

2012-04-30

2012-07-27

Terminated

United States

2014-06-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108946

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.

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.