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FDAJune 24, 2020device

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

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

The hazard

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

What to do

FDA enforcement status: Ongoing

Brands named

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Recall history

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

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