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FDADecember 11, 2017device

Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

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

The hazard

Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

What to do

FDA enforcement status: Terminated

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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