Stryker 5.0mm Egg Bur Recall Due to Missing Notches
Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.
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, 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 144 units of the Stryker 5.0mm Egg Bur Sterile device. 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.
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. The specific part number is 5820-15-50 and the lot number is 13343017.
The affected units were distributed worldwide, including nationwide in the United States. Healthcare providers and facilities should stop using the affected devices and contact Stryker for further instructions on the recall.
The recalled product
- Product
- Stryker 5.0mm Egg 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 including ma
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 144
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 5820-15-50
- Lot Number 13343017
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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