Z-0591-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- August 10, 2017
- Termination Date
- August 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 Units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
USA (nationwide)
Code Information
The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).