The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2726-2024·Announced 2024-09-04

Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk

Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.

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 a Class II FDA recall for a surgical device with potential to cause tissue damage requiring medical intervention. No injuries or hospitalizations have been reported in the source text, and the hazard is stated as potential rather than confirmed. Per the severity rubric, this qualifies as High (score 3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Corporation is recalling approximately 1,706 units of the iBur 4.0mm Diamond Round, Distal Bend surgical bur (reference: 8431-012-040D). This bur is used to cut bone in neurosurgery, spine surgery, ear/nose/throat procedures, and endoscopic applications, including drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing.

The recall was issued because these burs may operate at temperatures higher than the manufacturer's specification where the bur shank meets the distal bushing. This thermal overheating could potentially cause minor tissue or structure damage, or more serious tissue damage from thermal injury, which may require medical or surgical intervention.

The affected burs were distributed worldwide, including throughout the United States, Australia, Canada, France, Hong Kong, India, Italy, Japan, the Netherlands, South Korea, Spain, Sweden, Taiwan, and the United Kingdom. Lot numbers of affected units are: 22334017, 22339017, 23004017, 23016017, 23085017, 23115017, 23195017, and 23299017. The FDA has classified this as a Class II recall.

Healthcare facilities using these burs should immediately stop using the affected lots and contact Stryker Corporation for replacement units or further instructions. Verify the lot number on your bur packaging against the list of recalled lots to determine if your units are affected.

The recalled product

Product
Stryker iBur 4.0mm 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 Bone-Cutting Tool
Hazard
Affected units
1,706

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.

See all 10 products in this recall →

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