Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.
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 defect involves a manufacturing issue (missing notches) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 916 units of the 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile cutting accessories. The recall involves specific part numbers and lot numbers distributed worldwide, including nationwide in the United States.
The recall was initiated because some of the cutting accessories may have missing notches, partial notches, or no notches at all. These accessories are used with Elite Attachments to cut bone and bone-related tissue during neurosurgery, spinal surgery, and other surgical applications.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker for instructions on how to return or replace them. The devices are intended for use in procedures such as craniotomy, vertebral fusion, and cochlear implant surgery.
The recalled product
- Product
- Stryker 3.0mm x 3.8mm Neuro Drill Less 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 916
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 (3)
- Part Number 5820-107-430S1
- Lot Number 14003017
- 14005017
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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