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FDASeptember 25, 2023device

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

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

The hazard

Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.

What to do

FDA enforcement status: Ongoing

Brands named

encore medical lpencoreencore medical

UPCs

00888912144667

Recall history

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

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