Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk
Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall with a theoretical thermal injury hazard. No illnesses or injuries have been reported. The source text indicates a potential risk without documented harm, meeting the rubric criterion for a High rating (score 3).
Plain-English summary
Stryker Corporation is recalling iBur 3.0mm Precision Round surgical burs with distal bend configuration. These precision cutting instruments are used in neurosurgery, spine surgery, otolaryngology (ear/nose/throat), and endoscopic surgical procedures for bone cutting including drilling, reaming, and shaping. Approximately 1,612 units have been distributed worldwide, including throughout the United States and to Australia, Canada, France, Hong Kong, India, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom.
The recall was issued because the burs may exhibit temperatures higher than specification at the junction where the bur shank meets the distal bushing. Elevated temperatures in this area create a potential for tissue or structural damage from thermal injury, which may require medical or surgical intervention.
Healthcare facilities and surgical teams should verify that any iBur 3.0mm Precision Round burs in use match the affected lot numbers: 22224017, 22234017, 22234027, 22250017, 22293017, 22299017, 23157017, 23179017, 23179027, and 23299017. Units with these lot numbers should not be used. The product GTIN is 07613327501247.
The recalled product
- Product
- Stryker iBur 3.0mm 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…
- Manufacturer
- Stryker Corporation
- Affected units
- 1,612
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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