MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
This recall has been terminated (originally issued October 25, 2021).
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- October 25, 2021
- Terminated
- June 12, 2024
- Recall Number
- Z-1410-2022
- Quantity
- 9 pieces
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Distribution
US: CA, FL, GA, IL, OH & MI
Lot / Code Info
UDI-DI: 04046964067648
Root Cause
Component design/selection
Action Taken
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.