FDA recall Z-0803-2018

Zimmer Biomet, Inc. · Class II · device

Product

The 2nd Assist Knee Positioner

Reason for recall

Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.

Distribution

Nationally

Key facts

Status: Terminated
Initiation date: 2017-09-07
Report date: 2018-03-07
Termination date: 2018-08-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0803-2018