FDAFebruary 1, 2018device

smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity ...

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

The hazard

The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.

What to do

FDA enforcement status: Terminated

Brands named

smith nephewsmithsmith nephew

Recall history

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

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