medical Class II Updated 2021-09-29

Aesculap Implant Systems LLC recalls Univation X System Tray Sysem knee implant devices as follo

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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