Orthofix recalls specific drill bits (catalogue ref 1-1355001) due to lower cutting performance. Affected units have UDI codes 0118054242S10918 and lots 300244, 300243, 289816, 273348.
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 specific catalogue number due to lower cutting performance. This could affect surgical procedures where precise drilling is needed.
The drill bits have a geometrical detail that doesn't match the intended design. This leads to lower cutting performance, which could impact surgical precision during procedures.
Surgical professionals using these drill bits for medical procedures are most likely affected. Patients undergoing surgery with these bits may experience reduced precision.
Check for the catalogue number 1-1355001 on the drill bits. Look for UDI code 0118054242S10918 and lot numbers 300244, 300243, 289816, or 273348.
Identify the catalogue number and UDI code on the drill bit to confirm if it's affected.
The drill bits have a geometrical detail that doesn't match the intended design, leading to lower cutting performance.
Check the catalogue number and UDI code to see if it's affected; the recall doesn't require immediate action.
Yes, affected lot numbers are 300244, 300243, 289816, and 273348.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0385-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0385-2020 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.
