Data Foundry

Medical device recalls 2022

Stryker USB Converter — Class II medical device recall Z-1735-2022

Terminated recall by Mako Surgical Corporation, reported 2022-09-21, distributed in AZ, IL. Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have t

Recall numberZ-1735-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMako Surgical Corporation, Weston, FL, United States
Recall initiated2022-08-08
Classified2022-09-09
Reported by FDA2022-09-21
Terminated2026-05-22
DistributedAZ, IL
Quantity2
UPC / GTIN / UDI-DI07613327407280
Lot numbers22041607
Model numbers201148

Product

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1735-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.