Stryker 4.5mm Round Fluted Bur Recall for Missing Notches
Stryker is recalling 62 units of 4.5mm Round Fluted Bur Aggressive Sterile devices due to 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, and the source text describes a manufacturing defect (missing notches) without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 62 units of the 4.5mm Round Fluted Bur Aggressive Sterile device. The product is identified by Part Number 5820-10-245 and Lot Number 13350017. 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 some of the cutting accessories used with the Elite Attachments may have missing notches, partial notches, or no notches at all. The source text does not report any specific injuries or illnesses associated with this defect.
The affected units were distributed worldwide, including nationwide distribution in the United States. Users of these devices should contact Stryker for further instructions regarding the recall.
The recalled product
- Product
- Stryker 4.5mm 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
- 62
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 5820-10-245
- Lot Number 13350017
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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