Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press. Recalled by Stryker Instruments Div. of Stryker Corporation Due to Lack of sterility assurance as bioburden levels were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.
Affected Products
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Quantity: 732
Why Was This Recalled?
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Where Was This Sold?
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
About Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report