Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery
Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or 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: FDA Class II medical device recall of a surgical instrument with potential for thermal injury to tissue during use. No illnesses or injuries have been reported. Meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling iBur 4.0mm Precision Round surgical burs with distal bends used in neurosurgery, spine surgery, otolaryngology, and endoscopic procedures. The affected product is identified as Ref: 8431-009-040. A total of 1,227 units were distributed worldwide, including throughout the United States and internationally to Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom.
The burs may exhibit temperatures higher than their design specifications at the point where the shank meets the distal bushing. Excessive heat at this junction during surgical use could result in minor tissue or bone damage, or thermal injury to surrounding structures, potentially requiring additional medical or surgical intervention.
Healthcare facilities and surgeons using these burs should immediately stop use of affected lot numbers: 22245017, 22248017, 22270017, 22299017, 22306027, and 23188017. Affected units can be identified by GTIN 07613327501223. Healthcare providers should contact Stryker Corporation regarding replacement or refund options. No injuries or illnesses related to this defect have been reported.
The recalled product
- Product
- Stryker iBur 4.0mm Precision 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)/ Otorhinolaryngology; an
- Manufacturer
- Stryker Corporation
- Hazard
- thermal-injury
- heat-related-damage
Distribution
Distributed nationwide across the United States.
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