Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 301 sterile 6.0mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.
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, and the defect is a physical manufacturing issue (missing notches) rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 301 units of the 6.0mm Round Fluted Bur Aggressive Sterile device. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected devices are identified by Part Number 5820-10-260 and Lot Number 13346017.
The recall was initiated because some of the cutting accessories used with the Elite Attachments 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, including craniotomy and spinal surgery, as well as ear, nose and throat (ENT), orthopedic, and general surgical applications.
The affected units were distributed worldwide, including nationwide distribution in the United States. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Stryker 6.0mm Round Fluted Bur Aggressive 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 appli
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 301
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 5820-10-260
- Lot Numbers 13346017
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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