Device product
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.
Z-0980-2025
Product summary
- Event
- Event 95996
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 491 devices
- Official record key
device-enforcement:Z-0980-2025
Official wording
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 contains a 5820-107-530 device).
Code information: GTIN 04546540362483, Lot Number 21341057
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Derived failure modes
-
Unknown
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).