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Recall Observatory FDA recall evidence

Device product

POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.

Z-0952-2015

December 03, 2014

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 70032
Status
Terminated
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-0952-2015

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: Lot # - CA14C107

Distribution pattern: US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.

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.