Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use 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 source text does not report any hospitalizations or injuries. The defect involves missing notches on a surgical instrument, which is a functional issue rather than a direct contamination or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 27 units of the Stryker 0.5mm Round Fluted Bur Sterile. 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 used with Elite Attachments to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The affected products are identified by Part Number 5820-10-5 and Lot Number 13354017. The recall covers units 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 check their inventory for the specific part and lot numbers listed. If the affected devices are found, they should be removed from use and returned to Stryker or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Stryker 0.5mm 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
- 27
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 5820-10-5
- Lot Number 13354017
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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