CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA device recall Z-2363-2023 · posted 2023-08-09 · Open, Classified
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Reason for recall
- Incorrect Laser Marking - Solera Awl Tip Tap
- Action taken
- 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 letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records."
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 13 devices
- Distribution
- US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
- Date initiated
- 2023-07-12
- Date posted
- 2023-08-09
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS (K140454) | Medtronic Sofamor Danek USA, Inc. | 2014-05-22 |