Aesculap Implant Systems LLC MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI: 04046964067648
Products Sold
UDI-DI: 04046964067648
Aesculap Implant Systems LLC is recalling MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 due to Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, GA, IL, MI, OH
Page updated: Jan 10, 2026