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Recall Observatory FDA recall evidence

Device product

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Z-0866-2014

January 03, 2014

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 67203
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-0866-2014

Official wording

Reason: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Code information: TI13J01811

Distribution pattern: US Distribution in the states of CA, NC, TX, IN, NJ, and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.