Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL4…

Recall date

March 19, 2021

Source

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

Recall number

Z-2512-2021

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 knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION F MENISCAL COMP.T5 RM/LM 10MM; NL493 UNIVATION F MENISCAL COMP.T6 RM/LM 10MM