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Recall Observatory FDA recall evidence

Device product

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

Z-2515-2021

March 19, 2021

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 88325
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2515-2021

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

    reason.no_named_rule · v1.0.0

    Malfunction- loosening of the implant resulting in a potential revision surgery