Recall Z-2363-2023 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Sofamor Danek USA, Inc
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
| Date | Aug 9, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | Incorrect Laser Marking - Solera Awl Tip Tap |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignee on 07/12/2023 by UPS 2nd day mail. The notice explained the problem with the product, risk, and requested the following actions be taken immediately: " Identify and quarantine any impacted product(s). Return all impacted product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this lett |
| Quantity | 13 devices |
| Distribution | US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140454 | NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS Medtronic Sofamor Danek USA, Inc., May 22, 2014 |