Device product
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
Z-2513-2021
Product summary
- Event
- Event 88325
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2513-2021
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
Malfunction- loosening of the implant resulting in a potential revision surgery