FDA recall Z-1081-2019

Zimmer Biomet, Inc. · Class II · device

Product

Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

Reason for recall

Lack of an adequate sterilization validation

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-02-28
Report date: 2019-04-10
Termination date: 2020-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1081-2019