Z-0980-2025 Class II Ongoing
FDA device recall Z-0980-2025 was initiated by Stryker Corporation on June 28, 2023 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 491 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- June 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 491 devices
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).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Colombia, Sweden, Netherlands, UK.
Code Information
GTIN 04546540362483, Lot Number 21341057