Synthes recalls 3.5mm spinal screws that measure 4.0mm instead of 3.5mm. This size error could cause improper spinal fusion. Affected products include Part No. 04.615.026 sold under 10L2702.
The subject product measures 4.0mm in diameter instead of 3.5mm.
Synthes is recalling spinal screws that are too large (4.0mm instead of 3.5mm). This size error could lead to improper spinal fusion during surgery, potentially causing complications.
The screws are 4.0mm in diameter instead of the required 3.5mm. This size difference could cause improper spinal fusion, leading to instability or complications during recovery.
Spinal surgery patients who received the recalled screws (Part No. 04.615.026) during procedures. Surgeons and hospitals using these screws for spinal fusion are most at risk.
Check for the part number 04.615.026 on the screw packaging or label. The product was sold under the 10L2702 code for spinal surgery use.
Look for the part number 04.615.026 on the screw packaging or label to confirm if it's affected.
The screws measure 4.0mm instead of the required 3.5mm, which could cause improper spinal fusion.
Check the part number on the packaging or label. If it's 04.615.026, contact Synthes for guidance.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0223-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0223-2020 from Synthes. 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.
