Medtronic Sofamor Danek USA: Solera Awl Tip Tap with Incorrect Laser Marking
Medtronic Sofamor Danek USA recalls Solera Awl Tip Tap (REF NAV2006K) due to incorrect laser marking. Affected units include specific batch numbers and lot numbers from the SOLERA TAPS Kit.
Recall notice
Incorrect Laser Marking - Solera Awl Tip Tap
Contact the company
What happened, in plain English
Medtronic Sofamor Danek USA is recalling Solera Awl Tip Tap (REF NAV2006K) because of incorrect laser marking. This issue could lead to improper use in spinal surgery procedures. Read more at govinfonow.com/recall/57686-medtronic-sofamor-danek-usa-solera-awl-tip-tap-with-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/57686-medtronic-sofamor-danek-usa-solera-awl-tip-tap-with-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2363-2023
Cite this page
“Medtronic Sofamor Danek USA: Solera Awl Tip Tap with Incorrect Laser Marking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57686-medtronic-sofamor-danek-usa-solera-awl-tip-tap-with-incorrect. Based on FDA recall #Z-2363-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2363-2023%22&limit=1).
Why it’s dangerous
Incorrect laser marking on the Solera Awl Tip Tap could lead to improper identification or use during spinal surgery. This might cause errors in surgical procedures if the component is not correctly identified.
Who’s affected
Surgical professionals using the Solera Awl Tip Tap for spinal procedures are most at risk. Affected units include specific batch numbers and lot numbers from the SOLERA TAPS Kit.
How to tell if you have this one
Check for the product code REF NAV2006K on the Solera Awl Tip Tap. Affected units are packaged in the SOLERA TAPS Kit (REF 9735465) with specific batch numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200.
- Brand
Medtronic Sofamor Dan: a short, human brand name for headings (e.g.- Product
Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K- Category
Medical device
What to do — step by step
Check Product Details
Look for the product code REF NAV2006K on the Solera Awl Tip Tap and check the batch numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Florida, Indiana, South Carolina, Texas, Utah.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2363-2023 (July 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2363-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.