Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 188 sterile neuro drill accessories because some units have missing or partial notches, which may affect their use with Elite attachments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 does not report any injuries or illnesses, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 188 units of the Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile product. The recall is due to a manufacturing defect where some Cutting Accessories used with the Elite Attachments may have missing notches, partial notches, or no notches at all.
The affected 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 specific part number is 5820-107-40 and the lot number is 13339017.
The recall covers units distributed worldwide, including nationwide distribution in the US. The source text does not report any injuries or illnesses associated with this defect. Users should stop using the affected accessories and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 188
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 5820-107-40
- Lot Number 13339017
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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