FDAClass IISeptember 21, 2022

Stryker USB Converter recall

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

Why was Stryker USB Converter recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Recalling firm
Mako Surgical Corporation
Quantity
2
Distribution
US Distribution was made to IL and AZ.
Recall date
September 21, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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