Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
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: Class II device distributed to unintended home users without professional training. The risk of improper use of a surgical support tool by untrained consumers meets the rubric criteria for risk-of-harm products where injury has not been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling the Surgistool Model 830, a surgical support tool designed to assist healthcare professionals during surgical procedures. Four units with serial numbers 1202033898, 1206032470, 1406034563, and 1607037109 have been distributed in this recall.
The device was distributed to residential customers in multiple countries including the United States, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Although the product's labeling correctly identifies its intended use in healthcare facilities for professional use only, residential recipients may not be aware of or fully understand the instructions designed for healthcare professionals.
Consumers who have received this device outside an authorized healthcare facility should not attempt to use it without appropriate professional training. If you have obtained this device through a residential or consumer channel, contact Stryker Medical or your point of purchase for guidance on proper return and disposition.
The recalled product
- Product
- Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 4
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Medical Division 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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