Stryker recalls Revolution CMS surgical devices with higher-than-acceptable bioburden levels. These devices may not be sterile, risking infections during orthopedic procedures. Affected units have specific product numbers and lot numbers.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling certain Revolution CMS surgical devices because they contain higher-than-acceptable levels of bacteria, which could lead to infections during orthopedic surgeries. This recall affects devices used in hospitals and clinics for specific surgical procedures.
The devices have higher-than-acceptable levels of bacteria (bioburden), which means they may not be sterile when used. This could lead to infections during surgical procedures if the devices are not properly sterilized.
Healthcare professionals and hospitals using the recalled Revolution CMS devices for orthopedic procedures are most at risk. Patients undergoing surgery with these devices could face infection risks.
Check for the product number 0606-573-000 and lot number 17290012 on the device. The unique device identifier (UDI) is (01)4546540912114.
Look for the product number 0606-573-000 and lot number 17290012 on the device.
The devices have higher-than-acceptable levels of bacteria, which means they may not be sterile when used during orthopedic surgeries.
Check the device for the product number 0606-573-000 and lot number 17290012. If it matches, contact Stryker for further instructions.
The recall is due to potential infection risks from non-sterile devices, not direct injury risks like cuts or fires.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1252-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1252-2018 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.
