Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone 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 medical device with potential for thermal injury and tissue/bone damage during surgical use. No illnesses, injuries, or deaths have been reported to date; the hazard is theoretical. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling the iBur 4.0mm Coarse Diamond Round surgical burs (Ref: 8431-013-040DC) due to a potential defect affecting temperatures at the junction between the bur shank and distal bushing. The tool may reach temperatures higher than specification during use.
The recall affects 5031 units distributed in the United States and worldwide, including Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. The affected lot numbers include 22248017, 22263017, 22334017, 22348017, 22348027, 23016027, 23095027, 23128017, 23163017, 23179017, 23205017, 23205027, 23205037, 23221017, 23311017, 24004017, 24004027, and 24004037.
When temperatures exceed specification, the burs may cause minor or significant tissue and bone damage through thermal injury during surgical bone-cutting procedures. The device is intended for drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing bone in neurosurgery, spine surgery, otolaryngology, and endoscopic procedures.
The recalled product
- Product
- Stryker iBur 4.0mm 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
- Hazard
- thermal-injury
Distribution
Distributed nationwide across the United States.
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