Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Recall
- Recall Number
- Z-0721-2020
- Event Number
- 84328
- FEI Number
- 3005075696
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 2, 2019
- Terminated
- February 2, 2022
- Address
- Mazor Robotics Ltd North Industrial Park 5, Shacham Street Caesarea Israel
Description
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
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
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.
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
93 snapshot trackers