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Aesculap Implant Systems LLC recalls Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; N
Recalled September 29, 2021 · FDA recall Z-2509-2021 · 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 knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →