Orthofix recalls specific drill bits (catalogue ref 13550) due to design flaw causing lower cutting performance. Affected items have specific dimensions and 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 with a design flaw that may cause lower cutting performance. This affects medical-grade drill bits used in specific procedures. The issue does not pose a safety risk but impacts functionality.
The drill bits have a geometrical detail that does not match the intended design. This can lead to lower cutting performance during medical procedures. The issue is not a safety hazard but affects the tool's effectiveness.
Medical professionals using Orthofix drill bits for specific procedures are likely affected. Patients undergoing procedures with these drill bits may be impacted by reduced cutting performance.
Check for Orthofix catalogue number ref 13550, drill bit diameter 2.7 mm, length 127 mm, and lot numbers B1200674 or B1209688. These bits are for medical use only and non-sterile.
Verify the drill bit's catalogue number, dimensions, and lot numbers to confirm if it is affected.
No, the recall is for lower cutting performance, not a safety hazard.
Check the product details to confirm if it is affected; no action is needed if it is not listed.
Yes, they are safe but may have reduced cutting performance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0374-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0374-2020 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.
