Stryker 5.0mm Barrel Bur Recall for Missing Notches
Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may 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. The defect involves missing notches on a surgical instrument, which is a functional issue but does not involve a high-risk pathogen, structural vehicle defect, or reported hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling Stryker 5.0mm Barrel Bur Sterile devices. The recall is due to a manufacturing defect where some cutting accessories used with 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 5820-017-050S1 and the lot number is 14015017.
The recall covers worldwide distribution, including nationwide distribution in the US. The source text does not specify the number of units affected or report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Stryker 5.0mm Barrel Bur 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 including
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 1
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 5820-017-050S1
- Lot Number 14015017
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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