Z-2363-2023Class II

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Name: Z-2363-2023 CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Creator: Medtronic Sofamor Danek USA, Inc
Published: 2023-07-12
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2023-07-12 / Open, Classified

FDA source

Medtronic Sofamor Danek USA, Inc began a recall of CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K on 2023-07-12. FDA classified it as Class II and gives the reason as "Incorrect Laser Marking - Solera Awl Tip Tap". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2363-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-12
Posted: 2023-08-09
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Incorrect Laser Marking - Solera Awl Tip Tap
FDA 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 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."
Quantity in commerce: 13 devices
Distribution: US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2363-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2363-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-09

Product code OLO

K140454Class IINavigated Cd Horizon Solera Screwdriver/tapsMedtronic Sofamor Danek USA, Inc. / cleared 2014-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)