FDA recall Z-0721-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-07-02

Report date

2020-01-01

Termination date

2022-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caesarea, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2020