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Zimmer Biomet, Inc. recalls NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Recalled May 24, 2017 · FDA recall Z-2115-2017 · Zimmer Biomet
Hazard
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect. · FDA Class II
Units
24
Sold at
Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None
Description
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
Product
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →