Orthofix recalls ankle transfix pin sterile kits with specific lot numbers due to drill bits that may cause lower cutting performance. Affected kits include lot B1200695 and B1224714.
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Orthofix is recalling ankle transfix pin sterile kits with specific lot numbers because drill bits in some batches have a design flaw that may cause lower cutting performance. This could affect surgical procedures and requires checking your kit's lot number.
The drill bits in some batches have a geometrical detail that doesn't match the intended design. This could lead to lower cutting performance during surgical procedures, potentially affecting the effectiveness of the ankle fixation.
Patients undergoing ankle surgery who use the recalled ankle transfix pin sterile kits with lot numbers B1200695 or B1224714 are most at risk. Healthcare providers using these kits for surgical procedures may also be affected.
Check the lot number on the ankle transfix pin sterile kit packaging. Affected kits have lot numbers B1200695 or B1224714. The product is sold under the Orthofix brand with catalogue number 99-93503US.
Look for the lot number on the ankle transfix pin sterile kit packaging. Affected kits have lot numbers B1200695 or B1224714.
The drill bits in some batches have a geometrical detail that does not correspond to the intended design, which could result in lower cutting performance.
Check the lot number on the kit packaging. If it is B1200695 or B1224714, contact Orthofix for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0401-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0401-2020 from Orthofix. 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.
