FDA recall Z-0057-2021

Zimmer Biomet, Inc. · Class II · device

Product

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Reason for recall

The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

Distribution

Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.

Key facts

Status
Terminated
Initiation date
2020-08-14
Report date
2020-10-14
Termination date
2022-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0057-2021