NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is conducting a field action for two specific lots of NexGen Offset Stem Extension implants used in total knee replacements. The problem involves size labeling errors, where the size marked on the implant itself and printed on the product packaging do not match the actual size of the device. A total of 24 units were affected across two lots: Lot Number 63463357 (14mm size) and Lot Number 63463367 (17mm size), manufactured on September 19, 2016. These implants were distributed worldwide, including to nine U.S. states (Wisconsin, California, Pennsylvania, New Jersey, Indiana, Virginia, Washington, Minnesota, and Hawaii) and seven countries (Brazil, Canada, Australia, Netherlands, Germany, Iran, and Nigeria).
The source document does not specify what action affected consumers should take in response to this field action.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Quantity: 24 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.