Device product
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Z-0721-2020
Product summary
- Event
- Event 84328
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93 snapshot trackers
- Official record key
device-enforcement:Z-0721-2020
Official wording
Reason: 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
Code information: Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
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
Derived failure modes
-
Unknown
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