Orthofix recalls specific drill bits due to a design flaw that may cause lower cutting performance. Affected items have catalogue number ref 1100101 with specific lot numbers.
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 drill bits that may have lower cutting performance due to a design flaw. This could affect medical procedures requiring precise drilling.
The drill bits have a geometrical detail that doesn't match the intended design. This could lead to lower cutting performance during medical procedures, potentially affecting treatment effectiveness.
Medical professionals using these drill bits for procedures requiring precise drilling. Patients undergoing surgery with these bits may be at risk of less effective treatment.
Check for the catalogue number ref 1100101 with drill bit diameter 4.8 mm and length 180 mm. Affected lots include B1208414, B1218188, 289817, and 273349.
Identify the catalogue number ref 1100101 and specific lot numbers listed in the recall notice.
The drill bits have a geometrical detail that does not correspond to the intended design, which could result in lower cutting performance.
Check the catalogue number and lot numbers to see if your drill bit is affected. If it is, contact Orthofix for further instructions.
The recall is due to potential lower cutting performance, which may affect treatment effectiveness but does not pose a direct safety risk like injury or fire.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0375-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0375-2020 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.
