Orthofix recalls specific drill bits (catalog number 1100701) due to lower cutting performance. Affected items have a geometrical detail mismatch with intended design.
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 catalog number 1100701 that may have lower cutting performance due to a geometrical design mismatch. 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. The issue is specific to the manufacturing batch and not a safety hazard.
Medical professionals using these drill bits for surgical procedures are most at risk. Patients undergoing surgery with these bits may experience reduced cutting efficiency.
Check for the catalog number 1100701, drill bit diameter 4.8 mm, length 280 mm, and RX only (for medical use). The lot numbers B1200720, 289819, and 273352 are also associated with this recall.
Verify the catalog number, diameter, length, and lot numbers to confirm if your drill bit is affected.
The drill bits have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance during medical procedures.
Check for the catalog number 1100701, drill bit diameter 4.8 mm, length 280 mm, and RX only designation. Lot numbers B1200720, 289819, and 273352 are also affected.
The recall record does not specify a remedy, so you should contact Orthofix directly for further instructions.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0378-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0378-2020 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.
