Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no 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 source text describes a manufacturing defect (missing notches) without reporting any specific injuries, illnesses, or deaths. This aligns with the 'Moderate' severity criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 1,537 units of the Stryker 5.0mm Round Fluted Bur Aggressive Sterile. 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 specific part number is 5820-10-250, and the affected lot numbers are 13336017, 13339017, 13340017, and 13344017.
The recall is being conducted because there may be missing notches, partial notches, or no notches at all in some of the cutting accessories used with the Elite Attachments. This defect is a manufacturing issue that could affect the device's performance or safety during surgical procedures.
The affected devices were distributed worldwide, including nationwide distribution in the United States. Healthcare facilities and distributors should stop using the affected lots and contact Stryker for further instructions on returns or replacements.
The recalled product
- Product
- Stryker 5.0mm Round Fluted Bur 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 surgical appli
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 1,537
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 (5)
- Part Number 5820-10-250
- Lot Numbers 13336017
- 13339017
- 13340017
- 13344017
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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