Recall Z-2092-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
NexGen Precoat Stemmed Tibial Plate Size 5
| Date | Jul 5, 2023 (initiated May 19, 2023) |
| Status | Terminated |
| Reason | Device outer packaging was incorrectly labeled. |
| Root cause | Under Investigation by firm |
| Action | The firm distributed recall notifications by email on 5/19/2023. Customers are asked to review the recall notification and distribute to team members so they are aware of its contents. Additionally, customers are to identify and quarantine any affected devices, complete the provided Inventory Return Certification form, and ship affected product back to Zimmer. Customers are to retain a copy of the Inventory Return Certification for their records. Customers with any questions may call 574-371-3071 or email CorporateQuality.PostMarket@zimmerbiomet.com. |
| Distribution | International distribution in the country of India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling Zimmer, Inc., Mar 29, 2018 |