Stryker iBur surgical bur may overheat during bone-cutting procedures
Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.
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 medical device with potential for thermal tissue injury requiring possible surgical intervention. No illnesses or injuries reported, making this a risk-of-harm product where injury has not yet occurred, which qualifies as High severity per the rubric.
Plain-English summary
Stryker Corporation is recalling the iBur 3.0mm Diamond Match Head, Distal Bend, a surgical cutting tool used in bone surgery for neurosurgical, spinal, ear/nose/throat, and endoscopic procedures. Approximately 2,507 units were distributed worldwide, including throughout the United States and international markets.
The company identified a potential for the bur to reach temperatures higher than its specification at the junction between the shank and distal bushing. Excessive temperature may cause minor tissue or structural damage, or more serious thermal tissue injury that could require medical or surgical intervention.
No illnesses or injuries have been reported. Affected lot numbers include 22334017, 23047017, 23095017, and 23198017. Healthcare facilities should discontinue use of affected products and contact Stryker Corporation for replacement units.
The recalled product
- Product
- Stryker iBur 3.0mm Diamond Match Head, 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
- Manufacturer
- Stryker Corporation
- Hazard
- burn-injury
- tissue-damage
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 (1)
- GTIN: 07613327509229 Lot Numbers: 22334017 23047017 23095017 23198017
Distribution
Distributed nationwide across the United States.
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