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FDAAugust 7, 2020device

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

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

The hazard

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

What to do

FDA enforcement status: Ongoing

Brands named

encore medical lpencoreencore medical

UPCs

00888912144599

Recall history

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

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RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440 — Recall Details · AllClear