Recall Z-0591-2018 ยท HWT Template
Aesculap Implant Systems LLC
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.
| Date | Feb 12, 2018 (initiated Aug 10, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 13 Units |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.