FDA recall Z-0335-2020

Zimmer Biomet, Inc. · Class II · device

Product

Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Distribution

Distributed nationwide.

Key facts

Status: Terminated
Initiation date: 2019-10-10
Report date: 2019-11-13
Termination date: 2020-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2020