Z-2514-2021 Class II Terminated
FDA device recall Z-2514-2021 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: 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;
Reason for Recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution Pattern
US Nationwide distribution.
Code Information
All lots