FDA Device recall Z-1735-2022
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System
- FDA Device
- Class II
- terminated
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System by Mako Surgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1735-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-08 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mako Surgical |
| Distribution | AZ, IL |
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.
Identifiers
| code_info | Lot #22041607, UDI-DI (GTIN) 07613327407280. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1735-2022%22
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