Z-2115-2017 Class II Terminated
FDA device recall Z-2115-2017 was initiated by Zimmer Biomet, Inc. on April 28, 2017 and is designated Class II. 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 labe… The recall status is terminated (terminated July 3, 2018). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 28, 2017
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
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 Pattern
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
Code Information
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