NexGen Precoat Stemmed Tibial Plate Size 5
This recall is currently active, issued July 5, 2023. It was issued by Zimmer Inc..
- Company
- Zimmer Inc.
- Recall Initiated
- May 19, 2023
- Posted
- July 5, 2023
- Recall Number
- Z-2092-2023
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Device outer packaging was incorrectly labeled.
Distribution
International distribution in the country of India.
Lot / Code Info
Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.
Root 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.