Stryker surgical bur may overheat and cause thermal tissue damage
Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.
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: Potential for thermal injury in surgical equipment meets Score 3 criteria as a risk-of-harm product where injury has not yet been reported. No illnesses or deaths documented; hazard exceeds minor risk due to potential need for medical intervention.
Plain-English summary
Stryker Corporation is recalling approximately 2,507 units of the Stryker iBur 3.0mm Diamond Round surgical bur with distal bend. This surgical instrument is intended for bone cutting procedures including drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing in neurosurgery, spine surgery, ear/nose/throat (ENT), and endoscopic applications.
The recalled burs may exhibit temperatures higher than specification at the junction where the bur shank meets the distal bushing. Elevated temperatures may cause minor to significant thermal tissue damage or injury that could require medical or surgical intervention.
The affected units were distributed worldwide to the United States and the following countries: Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. Users should identify affected units using the product reference number 8431-012-030D and contact Stryker Corporation for further guidance regarding this recall.
The recalled product
- Product
- Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
- Manufacturer
- Stryker Corporation
- Affected units
- 2,507
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by 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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