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Zimmer, Inc. recalls VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length comb
Recalled September 4, 2013 · FDA recall Z-2094-2013 · Zimmer
Hazard
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. · FDA Class II
Units
85, 794 units in total
Sold at
Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
Description
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →