Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall
Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue 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 recall with potential for patient harm (thermal injury-related tissue or structural damage requiring medical/surgical intervention). No reported illnesses or injuries are stated in the source, and the language describes a potential risk rather than confirmed harm, keeping this at High rather than Severe.
Plain-English summary
Stryker Corporation is recalling the iBur 2.0mm Diamond Round, Distal Bend surgical burr (Ref: 8431-012-020D) due to a thermal hazard. The affected burr may exhibit temperatures higher than specification where the bur shank meets the distal bushing.
This thermal condition could lead to tissue or structural damage from thermal injury, which may require medical or surgical intervention. The affected units include 1,226 burrs distributed worldwide, including to healthcare facilities in the United States, Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. Lot numbers affected are: 22237017, 22241017, 22334017, 23085017, 23179017, 23213017, 24003017, and 24015017.
Healthcare providers and facilities currently using these burrs should discontinue use of the affected lot numbers and contact Stryker Corporation with questions regarding the recall or to obtain a replacement product.
The recalled product
- Product
- Stryker iBur 2.0mm 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)/ Otorhinolaryngology; and
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical Burr
- Hazard
- thermal-injury
- tissue-damage
Distribution
Distributed nationwide across the United States.
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