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FDASeptember 27, 2018device

ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

What to do

FDA enforcement status: Terminated

Brands named

orthofix srlorthofix

UPCs

18033509855962

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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