Stryker iBur surgical burs recalled due to overheating risk
Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.
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: FDA Class II surgical bur with potential thermal injury risk at the bur-bushing interface. No illnesses or injuries have been reported, making this a risk-of-harm scenario that qualifies for High severity per the rubric.
Plain-English summary
Stryker Corporation is recalling the iBur 3.0mm Coarse Diamond Round surgical bur with distal bend (Reference 8431-013-030DC). This instrument is used to cut bone during neurosurgery, spinal surgery, ear/nose/throat procedures, and endoscopic applications. Approximately 2,670 units have been distributed worldwide, including throughout the United States, Australia, Canada, France, Hong Kong, India, Italy, Japan, the Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom.
The product exhibits temperatures higher than specifications where the bur shank meets the distal bushing. This overheating could potentially lead to minor or significant tissue or structural damage from thermal injury, some cases of which may require medical or surgical intervention.
Healthcare facilities and surgical teams using these burs should be aware of the overheating risk. Users in possession of the affected lot numbers—22230017, 22333017, 22342017, 23011017, 23093017, 23172017, 23188017, 23221017, 23311017, and 24004027—should contact Stryker Corporation regarding the recalled units and recommended actions.
The recalled product
- Product
- Stryker iBur 3.0mm Coarse 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)/ Otorhinolaryngolo
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical bur
- Hazard
- thermal-injury
- tissue-damage
- overheating
Distribution
Distributed nationwide across the United States.
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