Recall Z-2092-2023
Zimmer, Inc. · initiated May 19, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NexGen Precoat Stemmed Tibial Plate Size 5
Codes / lots: Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.
Reason for recall
Device outer packaging was incorrectly labeled.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2092-2023
- Initiated
- May 19, 2023
- Posted by FDA
- July 5, 2023
- Terminated
- May 29, 2026
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Distribution
- International distribution in the country of India.
- Recalling firm
- Zimmer, Inc., Warsaw, IN