Recall archive / FDA device enforcement
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 — FDA record Z-2603-2023
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 Aug 4, 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 Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
- Reason
- Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
- Classification
- Class II
- Recalling firm
- Encore Medical, LP
- Quantity
- 20
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2603-2023
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/Lot/Expiration: 00190446258032/308V1112/May 25, 2029 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
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
- Sep 27, 2023
- Recall initiation date
- Aug 4, 2023
- Center classification date
- Sep 19, 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.