Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches
Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could 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, but the source text describes a specific manufacturing defect (missing notches) without reporting any injuries, illnesses, or serious adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 39 units of the 3.5mm Zyphr Elite Round Fluted Bur (Sterile). The recall is due to a manufacturing defect where some cutting accessories may have missing notches, partial notches, or no notches at all. These devices are intended to be used to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The affected products are identified by Part Number 5820-10-635 and Lot Number 13354017. The recall covers units distributed worldwide, including nationwide distribution in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected burs and contact Stryker for instructions on return or replacement. Patients who have had surgery using these specific devices should contact their healthcare provider if they have concerns about the procedure.
The recalled product
- Product
- Stryker 3.5mm Zyphr Elite 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 appl
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 39
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 5820-10-635
- Lot Numbers 13354017
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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