FDAFDA · Food and drugs·Recall number Z-0414-2021
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - 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.
Published November 11, 2020 · Recall initiated: September 21, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- International distribution the country of Japan Only.
- Lot
- Lot Numbers: 13L6742 14L2479
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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