Stryker 5.0mm Acorn Bur Recalled for Missing Notches
Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.
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, and the defect involves a physical characteristic (missing notches) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 71 units of the Stryker 5.0mm Acorn Bur, a sterile cutting accessory. The product is identified by Part Number 5820-30-50 and Lot Number 13347017. These 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 recall was initiated because there may be missing notches, partial notches, or no notches at all in some of the cutting accessories used with the Elite Attachments. The source text does not report any specific injuries or illnesses associated with this defect.
The affected units were distributed worldwide, including nationwide distribution in the United States. Consumers and healthcare providers should stop using the affected products and contact Stryker for further instructions.
The recalled product
- Product
- Stryker 5.0mm Acorn 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
- 71
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 5820-30-50
- Lot Number 13347017
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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