Stryker iBur 3.0mm surgical burr recalled over thermal hazard
Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require 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 an FDA Class II medical device with a documented hazard—excess temperature at the shank-bushing junction—that poses potential for thermal injury requiring medical intervention. No reported illnesses or injuries have been documented, placing this in the risk-of-harm category.
Plain-English summary
Stryker Corporation is recalling the iBur 3.0mm Precision Match Head with Distal Bend surgical burr (Ref: 8431-107-530, GTIN: 07613327501193) across 16 affected lot numbers. The device is used in neurosurgery, spine surgery, ear-nose-throat procedures, and endoscopic applications for cutting and shaping bone.
The recalled burrs may exhibit temperatures higher than their design specification where the bur shank meets the distal bushing. This temperature elevation poses a potential risk of thermal injury to tissue and bone structures during surgical use, which may require additional medical or surgical intervention.
The affected units have been distributed worldwide, including throughout the United States and to Australia, Canada, France, Hong Kong, India, Italy, Japan, the Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. A total of 3,673 units are involved in this recall.
Healthcare providers should verify their inventory against the affected lot numbers and discontinue use of recalled devices pending resolution by the manufacturer. Any adverse events associated with the recalled device should be reported to the FDA or Stryker Corporation.
The recalled product
- Product
- Stryker iBur 3.0mm Precision 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)/ Otorhinolaryngolo
- Manufacturer
- Stryker Corporation
- Hazard
- thermal-injury
- temperature-defect
Distribution
Distributed nationwide across the United States.
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