Recall archive / FDA device enforcement
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 — FDA record Z-1247-2022
Reported terminated
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 Apr 13, 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
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Reason
- A Size 2 trial baseplate was assembled with Size 1 instrument sets.
- Classification
- Class II
- Recalling firm
- Medacta Usa Inc
- Quantity
- 50 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1247-2022
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 | Model Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
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
- Jun 15, 2022
- Recall initiation date
- Apr 13, 2022
- Center classification date
- Jun 7, 2022
- Termination date
- Oct 23, 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.