FDA recall Z-1524-2018

Zimmer GmbH · Class II · device

Product

Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

Reason for recall

A potential commingle that could result in the product in the package not matching the product on the outer label.

Distribution

There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.

Key facts

Status: Terminated
Initiation date: 2018-02-28
Report date: 2018-05-02
Termination date: 2019-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winterthur, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2018