1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, sha...
FDA Recall #Z-0063-2025 — Class II — September 5, 2024
Product Description
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
Reason for Recall
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
307 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Code Information
GTIN: 04546540362346 Lot number: 22329017
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated