FDA-Device2021-09-29Class II
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
Aesculap Implant Systems LLC
Hazard
Malfunction- loosening of the implant resulting in a potential revision surgery
Sold states
US Nationwide distribution.
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2021Don't want to check this manually?
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