FDAFDA · Food and drugs·Recall number Z-0258-2024
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Published November 15, 2023 · Recall initiated: September 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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