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FDADecember 22, 2023device

HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty

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

The hazard

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

What to do

FDA enforcement status: Ongoing

Brands named

howmedica osteonicshowmedica

UPCs

07613327144093

Recall history

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

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HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty — Recall Details · AllClear