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Terminated

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

FDA Recall Z-1735-2022 · Posted None

Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2022-08-08
Date Terminated2026-05-22
Product Quantity2

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.

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].

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution was made to IL and AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation · 2012-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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