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FDADecember 30, 2019device

TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

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

The hazard

Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

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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TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. — Recall Details · AllClear