Z-2092-2023 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-2092-2023 was initiated by Zimmer, Inc. on May 19, 2023 and is designated Class II. Reason for recall: Device outer packaging was incorrectly labeled. The recall status is terminated (terminated May 29, 2026). Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
July 12, 2023
Initiation Date
May 19, 2023
Termination Date
May 29, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

NexGen Precoat Stemmed Tibial Plate Size 5

Reason for Recall

Device outer packaging was incorrectly labeled.

Distribution Pattern

International distribution in the country of India.

Code Information

Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.