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Open, Classified

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

FDA Recall Z-2363-2023 · Posted 2023-08-09

Recalling FirmMedtronic Sofamor Danek USA, Inc
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2023-07-12
Product Quantity13 devices

Reason for Recall

Incorrect Laser Marking - Solera Awl Tip Tap

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 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

Distribution Pattern

US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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