Stryker Recalls Orthopedic Cement Mixers Due to Sterility Assurance Issues
Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a lack of sterility assurance, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 732 units of the Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press. (Product Number: 0606-573-000, UDI: (01)4546540912114). The product is intended for orthopedic use. The recall is being conducted because bioburden levels were found to be higher than internal acceptable rates, resulting in a lack of sterility assurance.
The affected devices were distributed in all 50 U.S. States and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and the United Kingdom. The specific lot number for the recalled units is 17290012.
Healthcare providers and facilities should stop using the affected devices and contact Stryker for instructions on return or replacement. Patients who have had these devices used in their care should consult their healthcare provider if they have concerns regarding the sterility of the equipment.
The recalled product
- Product
- Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 732
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 17290012 UDI: (01)4546540912114
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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