Stryker iBur surgical bur recalled for potential overheating at junction
Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury 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: This is a risk-of-harm medical device where no injuries, hospitalizations, or illnesses have been reported. The source text describes only a 'potential' for thermal injury; the hazard is theoretical without documented cases. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
Stryker Corporation is recalling 1171 units of its iBur 5.0mm Coarse Diamond Round, Distal Bend surgical bur (reference 8431-013-050DC). The burs are intended for bone-cutting procedures including drilling, reaming, and shaping in neurosurgery, spine, ear/nose/throat (ENT), and endoscopic applications.
The burs may exhibit temperatures higher than specified where the shank meets the distal bushing during use. This elevated temperature could lead to minor tissue damage or tissue damage from thermal injury that may require medical or surgical intervention.
The recall affects 1171 units with lot numbers 22224017, 22227017, 23087017, 23157017, 23188017, and 23342017. Distribution is worldwide, including US Nationwide and Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. Healthcare providers and facilities using these burs should contact Stryker Corporation immediately.
The recalled product
- Product
- Stryker iBur 5.0mm 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)/ Otorhinolaryngol
- Manufacturer
- Stryker Corporation
- Hazard
- thermal-injury
- tissue-damage
- overheating
Distribution
Distributed nationwide across the United States.
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