Stryker Elite Bur Recall Due to Missing Notches
Stryker is recalling 2.0mm Tapered Round Elite Burs because some units have missing or partial notches. The devices are used for cutting bone during surgery.
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 defect involves missing notches on a surgical instrument, which is a functional issue but does not involve a high-risk pathogen, structural vehicle defect, or reported hospitalizations, fitting the Moderate category for minor labeling or functional errors without reported harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling six units of the 2.0mm Tapered Round Elite Bur, sterile. The product is identified by Part Number 5820-10-320 and Lot Number 14009017. These 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 recall was initiated because there may be missing notches, partial notches, or no notches at all in some cutting accessories used with the Elite Attachments. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected units were distributed worldwide, including nationwide distribution in the United States. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Stryker 2.0mm Tapered Round Elite 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 applicati
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 6
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 5820-10-320
- Lot Numbers 14009017
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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