Z-0721-2020 Class II Terminated
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