Recall archive / FDA device enforcement
DJO EMPOWR Knee Punch Handle, REF: 801-05-040 — FDA record Z-0258-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DJO EMPOWR Knee Punch Handle, REF: 801-05-040
- Reason
- Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
- Classification
- Class II
- Recalling firm
- Encore Medical, LP
- Quantity
- 406
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0258-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Sep 29, 2023
- Center classification date
- Nov 7, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.