Zimmer Biomet, Inc. recalls NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
- Recall date
- April 28, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2115-2017
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- 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
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
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