🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 8, 2022 Mako Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot #22041607, UDI-DI (GTIN) 07613327407280.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mako Surgical Corporation
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #22041607, UDI-DI (GTIN) 07613327407280.

Distribution:

Distributed in: US, IL, AZ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1735-2022

Related Recalls

Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

Mako Surgical

Class I - Dangerous

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

Oct 23, 2020 Implants & Prosthetics Nationwide View Details →