FDAFDA · Food and drugs·Recall number Z-1410-2022
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Published July 27, 2022 · Recall initiated: October 25, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- US: CA, FL, GA, IL, OH & MI
- Lot
- UDI-DI: 04046964067648
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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