FDADecember 22, 2021device

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral ...

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

The hazard

Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.

What to do

FDA enforcement status: Ongoing

Brands named

synthes usa productssynthessynthes usa

UPCs

10886982297372

Recall history

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

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