Recalls / —

—#202406

Product

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

FDA product code

OLO — Orthopedic Stereotaxic Instrument

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K140454

Affected lot / code info

SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200

Why it was recalled

Incorrect Laser Marking - Solera Awl Tip Tap

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm

Medtronic Sofamor Danek USA, Inc

Address

4340 Swinnea Rd, Memphis, Tennessee 38118-6603

Distribution

Distribution pattern

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

Timeline

Recall initiated

2023-07-12

Posted by FDA

2023-08-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.