Recall archive / FDA device enforcement
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. — FDA record Z-0126-2023
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 12, 2022. 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
- EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
- Reason
- Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
- Classification
- Class II
- Recalling firm
- Encore Medical, LP
- Quantity
- 18
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0126-2023
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: 00888912167055/132T1085 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 2, 2022
- Recall initiation date
- Aug 12, 2022
- Center classification date
- Oct 21, 2022
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.