Z-0404-2021 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 21, 2020
- Termination Date
- December 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
Reason for Recall
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Distribution Pattern
International distribution the country of Japan Only.
Code Information
Lot Numbers: 15L4249 50P8888 M22