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FDAAugust 12, 2024device

ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1

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

The hazard

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

00854501006067

Recall history

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

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ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1 — Recall Details · AllClear