Z-0721-2020Class II

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

Name: Z-0721-2020 Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Creator: Mazor Robotics Ltd
Published: 2019-07-02
License: https://open.fda.gov/license/

Mazor Robotics Ltd / initiated 2019-07-02 / Terminated / root cause: manufacturing process

FDA source

Mazor Robotics Ltd began a recall of Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 on 2019-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0721-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Posted: 2019-12-20
Terminated: 2022-02-02
Recalling firm: Mazor Robotics Ltd
Product: Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Product code: OLO Orthopedic Stereotaxic Instrument
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
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 07/05/2019, a "Urgent: Medical Device Recall" notification letter was hand-delivered to affected customers. In addition to informing consignees about the recall, the letter also asked customers to take the following actions: 1. Your Medtronic representative will be visiting you to remove the affected Tracker(s) and provide you with replacement Tracker(s). 2. Please sign the Consignee Confirmation Form accompanying this notification, acknowledging that you have reviewed this information as well as received a replacement product, and please return it to your Medtronic representative. 3.Adverse events or quality problems experienced with this product should be reported to FDA and Medtronic: - Online at the FDA website (www.fda.gov) or call FDA at 1-800-FDA-1088. - E-mail Medtronic at [email protected] or call 1-888-826-5603. 4. If you have any questions regarding this communication, please contact Medtronic at 1-888-826-5603.
Quantity in commerce: 93 snapshot trackers
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
Product codes and lots: Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0721-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20

Product code OLO

K182077Class IIMazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd. / cleared 2018-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)