FDADecember 3, 2014device
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic sofamor danekmedtronicmedtronic sofamor
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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