FDA recall Z-0102-2018

Zimmer Biomet, Inc. · Class II · device

Product

ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

Reason for recall

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

Distribution

OH, MI and TX

Key facts

Status: Terminated
Initiation date: 2014-02-14
Report date: 2017-11-22
Termination date: 2020-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2018