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FDAApril 22, 2015device

regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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

The hazard

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

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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