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Zimmer Inc. recalls Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-
Recalled August 8, 2012 · FDA recall Z-2092-2012 · Zimmer
Hazard
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 · FDA Class II
Units
65 units
Sold at
Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
Description
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
Product
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Manufacturer(s)
Zimmer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →