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FDAAugust 22, 2023device

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

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

The hazard

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

What to do

FDA enforcement status: Ongoing

Brands named

encore medical lpencoreencore medical

UPCs

00888912167321

Recall history

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

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EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 — Recall Details · AllClear