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Recall Observatory FDA recall evidence

Device product

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Z-1410-2022

October 25, 2021

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 90544
Status
Terminated
Classification
Class II
Quantity
9 pieces
Official record key
device-enforcement:Z-1410-2022

Official wording

Reason: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

Code information: UDI-DI: 04046964067648

Distribution pattern: US: CA, FL, GA, IL, OH & MI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.