Medicalplastic recalls Ilizarov Wire Tensioner Model 71070341 with a manufacturing error causing a wrong plastic internal washer that may wear and break during autoclave sterilization, risking malfunction.
Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.
Medicalplastic is recalling Ilizarov Wire Tensioners with a specific model and serial numbers due to a manufacturing error. The internal washer is made of the wrong plastic material that could wear and break during sterilization, potentially causing the tensioner to malfunction.
The internal washer is made of the wrong plastic material that can wear and break during the sterilization process in an autoclave. This could cause the tensioner to malfunction, potentially leading to improper limb alignment or other medical complications.
Patients using Ilizarov Wire Tensioners for medical purposes are affected. Those with the specific model and serial numbers listed in the recall are most at risk.
Check for the model number 71070341 and the specific serial numbers listed in the recall notice. The product includes a unique device identifier (UDI) starting with (10)08033201842072.
Review the model number and serial numbers listed in the recall notice to confirm if your Ilizarov Wire Tensioner is affected.
Medicalplastic is recalling Ilizarov Wire Tensioners due to a manufacturing error where the internal washer is made of the wrong plastic material that could wear and break during sterilization, risking malfunction.
The recall notice does not specify a remedy, so contact Medicalplastic directly for guidance on next steps.
Check for the model number 71070341 and the specific serial numbers listed in the recall notice, including the unique device identifier (UDI) starting with (10)08033201842072.
We’ve drafted a message you can send Medicalplastic to request your refund or repair — edit it as you like.
Subject: Recall Z-0245-2022 — Medicalplastic Medicalplastic Hello, I own a Medicalplastic that is covered by recall Z-0245-2022 from Medicalplastic. 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.
