Z-2512-2021 Class II Terminated
FDA device recall Z-2512-2021 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: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION F MENISCAL COMP.T5 RM/LM 10MM; NL493 UNIVATION F MENISCAL COMP.T6 RM/LM 10MM
Reason for Recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution Pattern
US Nationwide distribution.
Code Information
All lots