Medtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance
Medtronic Navigation is recalling four BioTex Reusable Adapter Kits because they were distributed without FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling four units of the BioTex Reusable Adapter Kit, Part Number 401-021-1010. These kits are used during neurological surgical procedures as instrument guide holders in conjunction with the Medtronic StealthStation Image Guided Workstation System. The affected units were manufactured between 2008 and 2010 and are packaged non-sterile in a dedicated case for steam sterilization.
The recall is being conducted because the adapter kits were commercially distributed by BioTex without a cleared premarket 510(k) from the FDA. The kits do not have specific lot or code numbers for identification. The four units were distributed in the United States to the states of Florida, New Jersey, Arizona, and North Carolina.
Healthcare facilities that have received these kits should stop using them and contact Medtronic Navigation for instructions on return or disposal. Consumers are not expected to have these medical devices in their homes.
The recalled product
- Product
- BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned…
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 4
Distribution
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