Z-0721-2020 Class II Terminated
FDA device recall Z-0721-2020 was initiated by Mazor Robotics Ltd on July 2, 2019 and is designated Class II. 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 injur… The recall status is terminated (terminated February 2, 2022). Affected quantity: 93 snapshot trackers.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- July 2, 2019
- Termination Date
- February 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93 snapshot trackers
Product Description
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
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
Distribution Pattern
US: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia
Code Information
Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496