Stryker 5.0mm Barrel Bur Recall Due to Missing Notches
Stryker is recalling 15 units of 5.0mm Barrel Bur Sterile because some units may have missing or partial notches.
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, and the defect involves a physical characteristic (missing notches) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 15 units of Stryker 5.0mm Barrel Bur Sterile. The recall is due to a defect where some cutting accessories used with Elite Attachments may have missing notches, partial notches, or no notches at all.
The affected products are identified by Part Number 5820-17-50 and Lot Number 13345017. These items were distributed nationwide in the United States.
Healthcare providers and consumers should stop using the affected products and contact Stryker for instructions on how to proceed.
The recalled product
- Product
- Stryker 5.0mm Barrel Bur Sterile
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 15
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 5820-17-50
- Lot Number 13345017
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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