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FDAJune 18, 2019device

Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

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

The hazard

Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

What to do

FDA enforcement status: Terminated

Brands named

howmedica osteonicshowmedica

UPCs

07613327351576

Recall history

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

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