Device product
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.
Z-0404-2021
Product summary
- Event
- Event 86545
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12 units
- Official record key
device-enforcement:Z-0404-2021
Official wording
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Code information: Lot Numbers: 15L4249 50P8888 M22
Distribution pattern: International distribution the country of Japan Only.
Derived failure modes
-
Labeling or packaging
Incorrectly Labeled