Stryker recalls USB Converter and Polaris Spectra Camera (Catalog #201148) due to potential infant failures causing non-function or error lights. Affected units may need replacement.
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.
Stryker is recalling a USB converter and camera used in robotic surgery systems because some units may stop working or flash error lights during use. This could disrupt surgery procedures if the device fails unexpectedly.
The device may become non-functional or flash error lights during surgery, which could interrupt procedures. However, this is a potential issue rather than a guaranteed failure causing serious injury.
Surgical teams using the Mako Robotic-Arm Assisted Surgery system with the specific USB converter and camera model. Surgeons and medical staff are most at risk during procedures.
Check for the catalog number 201148 on the device. Units sold with lot number 22041607 or UDI-DI (GTIN) 07613327407280 are affected.
Look for the catalog number 201148 on the device or lot number 22041607.
The recall states potential infant failures like non-function or error lights, but no serious injury risk is mentioned. This is considered low risk.
Check for catalog number 201148 or lot number 22041607 on the device.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected model.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1735-2022 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1735-2022 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.