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FDAJanuary 9, 2017device

Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

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

The hazard

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

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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