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FDA (Device enforcement)Recalled 2023-08-22class ii

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

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).

Details from the source

Reason for recall: 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). Distribution: US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA. Quantity: 36 Lot/code info: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028

UPC codes

00888912167321

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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