The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuro
Summary
The FDA issued a Class II for The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used by Stryker Corporation. Reason: 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.
Details
Source
Device Recall
External ID
Z-0980-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
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.
Lot/Code Info: GTIN 04546540362483, Lot Number 21341057
Quantity Affected: 491 devices
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).
Distribution
Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-28
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0980-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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