Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 41 sterile neuro drill accessories due to missing or partial notches that may affect compatibility 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. The defect involves missing notches on accessories, which is a functional issue rather than a direct biological hazard or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 41 units of the 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile product. The recall is due to a manufacturing defect where some cutting accessories may have missing notches, partial notches, or no notches at all. These accessories are used with Elite attachments.
The 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 specific part number is 5820-107-25 and the lot number is 13346017.
The affected units were distributed worldwide, including nationwide in the United States. Healthcare providers and facilities should stop using the affected accessories and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker 2.5mm x 3.6mm 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
- Affected units
- 41
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 5820-107-25
- Lot Number 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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