FDA recall Z-2516-2021

Product

Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544

Reason for recall

Malfunction- loosening of the implant resulting in a potential revision surgery

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-03-19

Report date

2021-09-29

Termination date

2025-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2021