Recall Z-1735-2022 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
| Date | Aug 8, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 8/8/2022 on the same date notifying their customers of a correction for the Mako System's USB Converter, Polaris Spectra Camera. The letter provided the issue, potential hazard, potential harm, risk mitigation, and actions needed. The actions included informing users of the medical device correction and forwarding the letter to all individuals who need to be aware within their organization. Complete and sign the enclosed Business Reply Form and email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days. The custo |
| Quantity | 2 |
| Distribution | US Distribution was made to IL and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM Mako Surgical Corporation, Jun 6, 2012 |