Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following man...
FDA Recall #Z-2727-2024 — Class II — July 24, 2024
Product Description
Stryker iBur 3.0mm Coarse 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: 8431-013-030DC
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
2670 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: 07613327501209 Lot Numbers: 22230017 22333017 22342017 23011017 23093017 23172017 23188017 23221017 23311017 24004027
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated