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U.S. Department of Health and Human Services

Class 2 Device Recall Mazor X Stealth Edition Snapshot Orthopedic stereotaxic instrument

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 Class 2 Device Recall Mazor X Stealth Edition Snapshot Orthopedic stereotaxic instrumentsee related information
Date Initiated by FirmJuly 02, 2019
Create DateDecember 20, 2019
Recall Status1 Terminated 3 on February 02, 2022
Recall NumberZ-0721-2020
Recall Event ID 84328
510(K)NumberK182077 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductSnapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Code Information Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
FEI Number 3005075696
Recalling Firm/
Manufacturer		 Mazor Robotics Ltd
North Industrial Park
5, Shacham Street
Caesarea Israel
For Additional Information ContactMedtronic Customer Service
1888-8265603
Manufacturer 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
FDA Determined
Cause 2		Other
ActionOn 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 rs.navtechsupport@medtronic.com 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 Commerce93 snapshot trackers
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OLO
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