Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
This recall is currently active, issued August 8, 2022. It was issued by Mako Surgical Corporation.
- Company
- Mako Surgical Corporation
- Recall Initiated
- August 8, 2022
- Recall Number
- Z-1735-2022
- Quantity
- 2
- Firm Location
- Weston, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution was made to IL and AZ.
Lot / Code Info
Lot #22041607, UDI-DI (GTIN) 07613327407280.
Root Cause
Under Investigation by firm
Action Taken
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 customer was informed Stryker will replace non-conforming USB Converter, Polaris Cameras, within the scope of the notification with qualified parts unaffected by the nonconformance. If you have any questions, please email:bradley.curtis@stryker.com.