Ulrich Medical recalls neon3 OCT spinal stabilization screws with lot numbers U010577, U016620, U019084 due to potential torque failure during installation. Affected units may not hold properly under required force.
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Ulrich Medical is recalling specific spinal stabilization screws that may not hold securely during installation due to a production error. This could lead to improper spinal stabilization if used in medical procedures.
The screws have a production error that causes the weld seam to fail under the required torque of 3.5 Nm during installation. This means the screws might not hold securely in place when used in spinal stabilization procedures, potentially leading to improper fixation.
Medical professionals using the recalled screws for spinal stabilization procedures are most at risk. Patients receiving these screws during surgery may face complications if the screws fail to hold properly.
Check the lot numbers on the screws: U010577, U016620, or U019084. The product is the Ulrich medical neon3 OCT spinal stabilization system with the specific locking screw for crosslink, screw-to-screw.
Identify the lot number on the screw package to determine if it matches U010577, U016620, or U019084.
Due to a production error, the weld seam of the screw cannot reliably transmit the required torque of 3.5 Nm during installation.
The recall record does not specify a remedy, so contact Ulrich Medical directly for guidance.
The recall indicates a potential risk of improper spinal stabilization if the screws fail to hold securely during installation.
We’ve drafted a message you can send Ulrich Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1350-2020 — Ulrich Medical Ulrich Medical Hello, I own a Ulrich Medical that is covered by recall Z-1350-2020 from Ulrich Medical. 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.