Stryker Neuro Drill Soft Touch Recalled for Missing Notches
Stryker is recalling 802 sterile neuro drill accessories due to missing or partial notches that may affect compatibility 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. The defect involves missing mechanical notches which is a functional issue rather than a direct biological hazard, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 802 units of the Stryker 3.0mm x 3.8mm 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 notches are required for the accessories to be used correctly with Elite attachments.
The affected products are identified by Part Number 5820-107-30 and Lot Numbers 13351017 and 14007017. 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. The distribution pattern is listed as worldwide distribution, including nationwide distribution in the US.
Healthcare providers and facilities should stop using the affected devices and contact Stryker for further instructions. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Stryker 3.0mm x 3.8mm 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 appl
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 802
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 5820-107-30
- Lot Number 13351017
- 14007017
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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