FDA recall Z-1009-2018

Zimmer Biomet, Inc. · Class II · device

Product

fastener, fixation, nondegradable, soft tissue

Reason for recall

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Distribution

TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

Key facts

Status: Terminated
Initiation date: 2017-10-25
Report date: 2018-03-21
Termination date: 2020-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2018