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FDAFebruary 3, 2015device

Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and u...

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

The hazard

The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.

What to do

FDA enforcement status: Terminated

Brands named

synthes

UPCs

5090226509022445942814825384

Recall history

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

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