Z-0721-2020 Class II Terminated

Recalled by Mazor Robotics Ltd — Caesarea

FDA device recall Z-0721-2020 was initiated by Mazor Robotics Ltd on Jul 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… The recall status is terminated (terminated Feb 2, 2022). Affected quantity: 93 snapshot trackers.

Recall details

Product Type
Devices
Report Date
Jan 1, 2020
Initiation Date
Jul 2, 2019
Termination Date
Feb 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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0721-2020
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-0721-2020. Report a data issue: hello@regdatalab.com.