Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: dr...
FDA Recall #Z-2725-2024 — Class II — July 24, 2024
Product Description
Stryker iBur 3.0mm 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 Endoscopic applications Ref: 8431-012-030D
Reason for Recall
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.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2507 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
Code Information
GTIN: 7613327501230 Lot Numbers: 22216017 22230017 22334017 23004017 23004027 23009017 23157017 23208017 23233017 23233027 24003017
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated