Z-1735-2022Class II

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

Name: Z-1735-2022 Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted...
Creator: Mako Surgical Corporation
Published: 2022-08-08
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2022-08-08 / Terminated

FDA source

Mako Surgical Corporation began a recall of Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System on 2022-08-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1735-2022
Classification: Class II
Status: Terminated
Initiated: 2022-08-08
Posted: 2022-09-09
Terminated: 2026-05-22
Recalling firm: Mako Surgical Corp.
Product: Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
FDA 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 [email protected] 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:[email protected].
Quantity in commerce: 2
Distribution: US Distribution was made to IL and AZ.
Product codes and lots: Lot #22041607, UDI-DI (GTIN) 07613327407280.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1735-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1735-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-21	2022-09-09

Product code OLO

K121064Class IIMakoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation / cleared 2012-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)