Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
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, but the source text describes a manufacturing defect (missing notches) without reporting any injuries, illnesses, or specific patient harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 252 units of the 2.0mm Round Fluted Bur (Part Number 5820-10-20). The affected lots are 13347017 and 14010017. These sterile devices are intended to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The recall was initiated because some of the cutting accessories may have missing notches, partial notches, or no notches at all. These notches are required for the proper use of the devices with Elite Attachments. The FDA has classified this as a Class II recall.
The products were distributed worldwide, including nationwide in the United States. Healthcare providers and facilities that have these specific part and lot numbers should stop using the devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker 2.0mm Round Fluted 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 252
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 5820-10-20
- Lot Numbers 13347017
- 14010017
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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