FDA-Device2017-05-24Class II
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Zimmer Biomet, Inc.
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.
Sold states
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
Affected count
24
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2017Don't want to check this manually?
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