FDA recall Z-2233-2019

Zimmer Biomet, Inc. · Class II · device

Product

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812

Reason for recall

Cleaning processes potentially being ineffective

Distribution

Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.

Key facts

Status: Terminated
Initiation date: 2019-07-02
Report date: 2019-08-21
Termination date: 2021-09-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2019