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FDA (Device enforcement)Recalled 2023-09-29class ii

Encore Medical, LP: DJO EMPOWR Knee Punch Handle, REF: 801-05-040

Hazard

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

Details from the source

Reason for recall: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. Distribution: US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA Quantity: 406 Lot/code info: UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01

UPC codes

00190446238881

Source

Official record: FDA (Device enforcement)

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

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