Stryker Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 72 sterile 1.0mm 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. The defect involves missing or partial notches on a surgical instrument, which is a functional issue that could impact device performance but does not explicitly report injuries, deaths, or high-risk biological contamination in the source text.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 72 units of the Stryker 1.0mm Round Fluted Bur, sterile. The affected products are identified by Part Number 5820-10-10 and Lot Number 14005017. These 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.
The recall was initiated because there may be missing notches, partial notches, or no notches at all in some of the cutting accessories used with the Elite Attachments. This defect may affect the proper fit or function of the device when used with the specified attachments.
The affected units were distributed worldwide, including nationwide distribution in the United States. Healthcare providers and facilities that have received these specific lots should stop using the affected burs and contact Stryker for further instructions on return or replacement.
The recalled product
- Product
- Stryker 1.0mm 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 in
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 72
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 5820-10-10
- Lot Number 14005017
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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