Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mazor Robotics Ltd
- Reason for Recall:
- The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Product Codes/Lot Numbers:
Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0721-2020
Related Recalls
Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Mazor Robotics
Software update
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.