Recall archive / FDA device enforcement
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup — FDA record Z-1753-2024
Reported completed
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 Mar 7, 2024. 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
- INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
- Reason
- 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
- Classification
- Class II
- Recalling firm
- Innomed, Inc.
- Quantity
- 41 devices
- Agency-reported status
- Completed
- Source record identifier
- Z-1753-2024
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 00840277104007, Lot Number 1223K |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
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
- May 8, 2024
- Recall initiation date
- Mar 7, 2024
- Center classification date
- May 1, 2024
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.