Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2115-2017)
See the recall detail below. You can also see other recalls from the same firm in 2017.
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Class II
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.
Item Number: 00-5988-020-14, Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357; Item Number: 00-5988-020-17, Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026
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
Voluntary: Firm initiated