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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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)…
- Manufacturer
- Stryker Corporation
- Affected units
- 1,171
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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