MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
FDA Recall Z-1410-2022 · Posted None
Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHXX
Date Initiated2021-10-25
Date Terminated2024-06-12
Product Quantity9 pieces
Reason for Recall
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Firm 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 [email protected]. Distributors are to notify customers if product was further distributed.
Root Cause
Component design/selection
Distribution Pattern
US: CA, FL, GA, IL, OH & MI
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.