Stryker recalls iBur 4.0mm Diamond Round surgical burs for potential thermal injury during bone cutting procedures. Affected units have specific lot numbers and model codes. Contact Stryker for details.
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
Stryker is recalling certain iBur 4.0mm Diamond Round surgical burs that may overheat at the tip, potentially causing minor tissue damage or requiring medical intervention. This risk occurs during bone cutting procedures like drilling and reaming.
The bur's distal bushing may overheat during use, especially when drilling or reaming bone. This overheating could cause minor tissue damage or require medical/surgical intervention if the temperature exceeds safe levels.
Surgical professionals using the iBur 4.0mm Diamond Round burs for bone cutting procedures in neurosurgery, spine surgery, ENT, or endoscopic applications. Patients receiving these procedures are at risk if the bur overheats.
Check for lot numbers 22334017, 22339017, 23004017, 23016017, 23085017, 23115017, 23195017, or 23299017 on the packaging. The product is labeled as 'Stryker iBur 4.0mm Diamond Round, Distal Bend' for bone cutting procedures.
Review the lot number on the packaging to confirm if your iBur 4.0mm Diamond Round bur is affected.
The bur may overheat at the tip during bone cutting, potentially causing minor tissue damage or requiring medical intervention.
Check for lot numbers 22334017, 22339017, 23004017, 23016017, 23085017, 23115017, 23195017, or 23299017 on the packaging.
The recall does not specify a remedy, so contact Stryker directly for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2726-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2726-2024 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.