FDA Medical Device Recalls (openFDA)
Mazor Robotics Ltd: Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
- Recall number
- Z-0721-2020
- Recalling firm
- Mazor Robotics Ltd
- Product
- Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
- Status
- Terminated
- Initiated
- 2019-07-02
- Posted
- not on file
- Terminated
- 2022-02-02
- 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
- 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 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
- 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
- Lot, serial or model codes
- Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
- 510(k) numbers
- ["K182077"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005075696
- Firm city
- Caesarea
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28