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.
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.
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.
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.
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.
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.
Look for the lot number 0648247W on the screw head or attached data tag.
The screws have incorrect size markings (listed as 5.5mm but actually 5.0mm) which could lead to improper spinal fusion during surgery.
Check the lot number on the screw head or data tag. If it matches 0648247W, contact Medtronic for further instructions.
The recall does not specify that this could cause serious injury in normal use; the hazard is related to surgical misapplication.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2603-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2603-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
