Z-2516-2021 Class II Terminated
FDA device recall Z-2516-2021 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 Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
Reason for Recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution Pattern
US Nationwide distribution.
Code Information
All lots