Recall Z-1410-2022 ยท HXX Screwdriver
Aesculap Implant Systems LLC
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
| Date | Oct 25, 2021 |
| Status | Terminated |
| Reason | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. |
| Root cause | Component design/selection |
| Action | An Urgent Medical Device Removal Notification was issued October 25, 2021 sent via email and USPS certified mail. The notice identified the product MODULIFT VBR SZ.M 4MM SET SCREWDRIVER, part of Modulift VBR Medium Instrument Set, ST-0441 and requested customers identify and quarantine affected inventory, submit the acknowledgement form and contact AIS Customer Service to arrange for return of product at (866) 229-3002 and SetWorld_orders.BBMUS_Service@aesculapimplants.com. Distributors are to notify customers if product was further distributed. |
| Quantity | 9 pieces |
| Distribution | US: CA, FL, GA, IL, OH & MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.