Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a surgical instrument used to cut bone. While no injuries are reported, the potential for harm during surgery places this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 285 units of the 3.0mm Round Fluted Bur Aggressive Sterile device. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected devices are identified by Part Number 5820-10-230 and Lot Number 13343017.
The recall was initiated because some of the cutting accessories may have missing notches, partial notches, or no notches at all. These notches are required for the devices to be used correctly with the Elite Attachments. The devices are intended to cut bone and bone-related tissue during neurosurgery, ENT, orthopedic, and general surgical applications.
The affected units were distributed worldwide, including nationwide distribution in the United States. No specific illnesses or injuries are reported in the source text. Healthcare providers and consumers should stop using the affected devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker 3.0mm Round Fluted Bur Aggressive 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 appli
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 285
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 5820-10-230
- 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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