Stryker 6.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 256 units of 6.0mm Round Fluted Bur due to missing or partial notches that may affect compatibility with Elite Attachments.
What this means for you
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 defect is a mechanical compatibility issue (missing notches) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 256 units of the 6.0mm Round Fluted Bur (Part Number 5820-10-60, Lot Number 13343017). The recall is due to a manufacturing defect where some cutting accessories may have missing notches, partial notches, or no notches at all. These devices are intended to be used to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The affected products were distributed worldwide, including nationwide in the United States. The missing notches may impact the proper use of the devices with Elite Attachments. No specific injuries or illnesses have been reported in the source text.
Healthcare providers and facilities should stop using the affected lots and contact Stryker for instructions on return or replacement. Consumers should not use these medical devices if they are in their possession.
The recalled product
- Product
- Stryker 6.0mm Round Fluted Bur 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 applications incl
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 256
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 (2)
- Part Number 5820-10-60
- Lot Numbers 13343017
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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