Device product
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM; NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM; NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM;
Z-2514-2021
Product summary
- Event
- Event 88325
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2514-2021
Official wording
Reason: Malfunction- loosening of the implant resulting in a potential revision surgery
Code information: All lots
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Malfunction- loosening of the implant resulting in a potential revision surgery