The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and b...
FDA Recall #Z-0980-2025 — Class II — June 28, 2023
Product Description
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.
Reason for Recall
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
491 devices
Distribution
Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Code Information
GTIN 04546540362483, Lot Number 21341057
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.