Device 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
Z-2516-2021
Product summary
- Event
- Event 88325
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2516-2021
Official wording
Reason: Malfunction- loosening of the implant resulting in a potential revision surgery
Code information: All lots
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Malfunction- loosening of the implant resulting in a potential revision surgery