FDA-Device2021-09-29Class II
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
Aesculap Implant Systems LLC
Hazard
Malfunction- loosening of the implant resulting in a potential revision surgery
Sold states
US Nationwide distribution.
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2510-2021Don't want to check this manually?
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