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FDAOctober 29, 2024device

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

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

The hazard

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

03596010595072035960105950890359601065645203596010656469

Recall history

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

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BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. — Recall Details · AllClear