Stryker Recalls Four Zyphr Elite Round Fluted Bur Units
Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility 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. The hazard involves a mechanical defect (missing notches) that may affect device compatibility, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling four units of the 5.0mm Zyphr Elite Round Fluted Bur, sterile. The devices are intended 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 is due to a manufacturing defect where some cutting accessories used with the Elite attachments may have missing notches, partial notches, or no notches at all. This defect could impact the proper fit or function of the device when used with the corresponding attachments.
The affected units are identified by Part Number 5820-10-650 and Lot Number 14005027. The distribution pattern is listed as worldwide distribution, including nationwide distribution in the US. Healthcare providers and facilities should stop using these specific units and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker 5.0mm 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
- 4
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 5820-10-650
- Lot Number 14005027
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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