Orthofix recalls specific drill bits (catalogue ref 1100301) due to design flaw causing lower cutting performance. Affected units include certain lots and batch 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 surgical outcomes.
Medical professionals using these drill bits for surgical procedures are most at risk. Patients receiving these bits during surgery may be affected.
Check for Orthofix catalogue number ref 1100301, drill bit diameter 3.2 mm, length 200 mm. Affected lots include B1202045, B1206643, B1218524, and 273351.
Verify the catalogue number, diameter, and length to confirm if your drill bit is affected.
The recall does not require immediate stop use; the hazard is low risk and only affects cutting performance.
The recall does not specify a remedy, so contact Orthofix directly for further instructions.
Check for catalogue number ref 1100301, diameter 3.2 mm, length 200 mm, and affected lots: B1202045, B1206643, B1218524, 273351.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0377-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0377-2020 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.
