Recall Z-0591-2018
Aesculap Implant Systems LLC · initiated August 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998
Details
- Recall number
- Z-0591-2018
- Initiated
- August 10, 2017
- Posted by FDA
- February 12, 2018
- Terminated
- August 8, 2018
- Product code
- HWT – Template
- Quantity
- 13 Units
- Distribution
- USA (nationwide)
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA