Recall Z-0721-2020 ยท OLO Orthopedic Stereotaxic Instrument
Mazor Robotics Ltd
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
| Date | Jul 2, 2019 |
| Status | Terminated |
| 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.Adve |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182077 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., Nov 2, 2018 |