Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories
Stryker is recalling 497 sterile neuro drills because some cutting accessories 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, and the defect involves missing notches on accessories without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 497 units of the Stryker 3.0mm x 3.8mm Neuro Drill, Sterile. The devices are identified by Part Number 5820-107-430 and Lot Number 13350017. These sterile devices are intended 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 cutting accessories used with the Elite Attachments. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected products were distributed worldwide, including nationwide in the United States. Healthcare providers and facilities should stop using the affected devices and contact Stryker for further instructions or replacement.
The recalled product
- Product
- Stryker 3.0mm x 3.8mm Neuro Drill 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 497
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 5820-107-430
- 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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