Recall Z-2115-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
| Date | Apr 28, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet is conducting a voluntary recall for two lots of the NexGen Offset Stem Extension implants following product complaints indicating that the size etched on the part and labeled on the product packaging were incorrect. Zimmer Biomet distributed recall notices on April 28, 2017, via FedEx. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product |
| Quantity | 24 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933785 | NEXT GENERATION KNEE SYSTEM Zimmer, Inc., Jan 30, 1995 |