Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 609 sterile 3.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (missing notches) rather than a direct biological or physical injury risk, fitting the criteria for a moderate severity recall involving low-risk contamination or functional issues without reported harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 609 units of the 3.0mm Round Fluted Bur Soft Touch Sterile. These medical devices are intended to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical procedures. The recall is due to a manufacturing defect where some cutting accessories may have missing notches, partial notches, or no notches at all, which are required for use with Elite Attachments.
The affected products are identified by Part Number 5820-10-130 and Lot Numbers 13346017 and 13346027. The devices were distributed worldwide, including nationwide distribution in the United States. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and facilities should stop using the affected burs and contact Stryker for instructions on how to return or replace the devices. Patients who have had surgery using these specific devices should consult their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 609
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 (3)
- Part Number 5820-10-130
- Lot Numbers 13346017
- 13346027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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