FDA recall Z-0115-2018

Zimmer Biomet, Inc. · Class II · device

Product

ROSA Surgical Device 2.5.8

Reason for recall

Potential for software to change the final tool orientation for the command position without command.

Distribution

AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

Key facts

Status: Terminated
Initiation date: 2016-04-08
Report date: 2017-11-29
Termination date: 2020-07-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2018