Z-2515-2021 Class II Terminated
FDA device recall Z-2515-2021 was initiated by Aesculap Implant Systems LLC on March 19, 2021 and is designated Class II. Reason for recall: Malfunction- loosening of the implant resulting in a potential revision surgery The recall status is terminated (terminated March 28, 2025).
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution Pattern
US Nationwide distribution.
Code Information
All lots