ProductGuru Recalls

Official recall record

Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, sha

US FDA — Medical Devices · 2024-07-24 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2024-07-24
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
07613327501186
Brand on record
Stryker Corporation

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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