Medtronic CD HORIZON Spinal System: Incorrect Screw Size Marking Risk
Medtronic recalls CD HORIZON Spinal System screws with incorrect 5.5mm marking (actual 5.0mm) that could lead to improper spinal fusion. Affected units sold in 2023 with specific lot numbers.
Recall notice
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
Contact the company
What happened, in plain English
Medtronic is recalling spinal screws that have been incorrectly marked as 5.5mm when they are actually 5.0mm. This mismatch could cause improper spinal fusion if used in surgery. The recall affects specific lot numbers sold in 2023. Read more at govinfonow.com/recall/70652-medtronic-cd-horizon-spinal-system-incorrect-screw-size-marking-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/70652-medtronic-cd-horizon-spinal-system-incorrect-screw-size-marking-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2603-2018
Cite this page
“Medtronic CD HORIZON Spinal System: Incorrect Screw Size Marking Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70652-medtronic-cd-horizon-spinal-system-incorrect-screw-size-marking-risk. Based on FDA recall #Z-2603-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2603-2018%22&limit=1).
Why it’s dangerous
The screws have incorrect size markings on both the screw head and the data tag. This could lead to using the wrong screw size during spinal surgery, potentially causing improper spinal fusion or complications.
Who’s affected
Patients who received the CD HORIZON Spinal System with lot number 0648247W in 2023 are most at risk. Surgeons and medical facilities using this specific model may also be affected.
How to tell if you have this one
Check for the lot number 0648247W on the screw head or data tag. The screws were sold in 2023 as part of the CD HORIZON Spinal System for spinal fusion procedures.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot number 0648247W on the screw head or attached data tag.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-2603-2018 (July 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2603-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.