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Recall Observatory FDA recall evidence

Device product

Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

Z-0721-2020

July 02, 2019

Class II

Product summary

Firm
Mazor Robotics Ltd
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

    reason.no_named_rule · v1.0.0

    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