Device product
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
Z-0591-2018
Product summary
- Event
- Event 79042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 Units
- Official record key
device-enforcement:Z-0591-2018
Official wording
Reason: The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
Code information: The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
Distribution pattern: USA (nationwide)
Derived failure modes
-
Labeling or packaging
incorrectly labeled