Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following man...
FDA Recall #Z-2731-2024 — Class II — July 24, 2024
Product Description
Stryker iBur 3.0mm Precision Match Head, 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: 8431-107-530
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
3673 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: 07613327501193 Lot Numbers: 22228017 22257017 22269017 22276017 23085017 23095017 23157017 23157027 23179017 23179027 23198017 23213017 23221017 23299017 23345017 23345027
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated