FDA recall Z-2092-2023

Zimmer, Inc. · Class II · device

Product

NexGen Precoat Stemmed Tibial Plate Size 5

Reason for recall

Device outer packaging was incorrectly labeled.

Distribution

International distribution in the country of India.

Key facts

Status
Ongoing
Initiation date
2023-05-19
Report date
2023-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2092-2023