Recall archive / FDA device enforcement
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery ... — FDA record Z-1735-2022
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 Aug 8, 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
- Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Reason
- Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
- Classification
- Class II
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 2
- Agency-reported status
- Terminated
- Source record identifier
- Z-1735-2022
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 | Lot #22041607, UDI-DI (GTIN) 07613327407280. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution was made to IL and AZ.
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 21, 2022
- Recall initiation date
- Aug 8, 2022
- Center classification date
- Sep 9, 2022
- Termination date
- May 22, 2026
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.