FDAJuly 22, 2015device
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
Recall history
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