MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of… recallZ-1410-2022 · Aesculap Implant Systems LLC · initiated Oct 25, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1410-2022
- Status
- Terminated
- Initiated by the company
- Oct 25, 2021
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 9 pieces
- Product code
- HXX
- Distribution
- US: CA, FL, GA, IL, OH & MI
Product description
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Code information (models, lots, serial numbers)
UDI-DI: 04046964067648
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MODULIFT MF790RAesculap Implant Systems, LLC · SCREWDRIVER1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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