Aesculap Implant Systems LLC recalls Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set S…

Recall date

March 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2516-2021

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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