Orthofix recalls specific tibia-femur sterile kits due to drill bits with design flaws that may cause lower cutting performance. Affected kits have UDI (01)18054242S511298 and lot B1225603.
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 a specific tibia-femur sterile kit because some drill bits have a design flaw that could lead to lower cutting performance. This issue might affect surgical procedures where precise cutting is needed.
The drill bits in the recalled kit have a geometrical detail that doesn't match the intended design. This could cause lower cutting performance during surgical procedures, potentially affecting the precision of the surgery.
Surgical teams using the recalled tibia-femur sterile kit with UDI (01)18054242S511298 and lot B1225603 are most at risk. Patients undergoing surgery with this kit could experience reduced cutting efficiency.
Check for the UDI (01)18054242S511298 and lot number B1225603 on the kit's packaging. The product is sold under Orthofix's catalog number 99-93502US.
Identify the UDI (01)18054242S511298 and lot number B1225603 on the kit's packaging to confirm if it's affected.
Orthofix recalls this specific tibia-femur sterile kit because some drill bits have a design flaw that could lead to lower cutting performance during surgery.
Check for the UDI (01)18054242S511298 and lot number B1225603 on the kit's packaging. The product is sold under Orthofix's catalog number 99-93502US.
The recall record does not specify a remedy, so contact Orthofix directly for guidance on next steps.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0399-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0399-2020 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.
