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Aesculap Implant Systems LLC recalls Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set
Recalled September 29, 2021 · FDA recall Z-2516-2021 · Aesculap Implant Systems
Hazard
Malfunction- loosening of the implant resulting in a potential revision surgery · FDA Class II
Sold at
US Nationwide distribution.
Description
Malfunction- loosening of the implant resulting in a potential revision surgery
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
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →