FDA-Device2021-09-29Class II
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189
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: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2021Don't want to check this manually?
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