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Recall Observatory FDA recall evidence

Device product

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

Z-0258-2024

September 29, 2023

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 93214
Status
Ongoing
Classification
Class II
Quantity
406
Official record key
device-enforcement:Z-0258-2024

Official wording

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

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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