Orthofix recalls specific drill bits (catalog #1100201) due to design flaw causing lower cutting performance. Affected units sold with certain 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 specific 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 precision and safety.
Medical professionals using these drill bits for procedures requiring precise drilling. Patients undergoing surgery with these bits may be at slightly higher risk due to potential cutting issues.
Check for Orthofix Catalogue Number: ref 1100201, drill bit diameter 4.8 mm, length 240 mm. Affected units include lot numbers B1202045, B1206643, B1218524, 289818, and 273350.
Verify the catalogue number, diameter, and length to confirm if your drill bit is affected.
Orthofix determined that certain batches have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance.
The recall record does not specify a remedy, so check the product details to see if it's affected and contact Orthofix for further guidance.
Yes, affected lot numbers include B1202045, B1206643, B1218524, 289818, and 273350.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0376-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0376-2020 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.
