CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Recall
- Recall Number
- Z-2363-2023
- Event Number
- 92749
- Firm
- Medtronic Sofamor Danek USA, Inc
- FEI Number
- 3003120897
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 12, 2023
- Posted
- August 9, 2023
- Address
- 4340 Swinnea Rd, Memphis, TN, 38118-6603
Description
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Incorrect Laser Marking - Solera Awl Tip Tap
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."
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
13 devices