Orthofix recalls ankle sterile kits with specific UDI numbers due to drill bits that may cause lower cutting performance. Affected kits have UDI (01)18033509859922 and lots B1200695/B1224714.
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 ankle sterile kits with specific UDI and lot numbers because drill bits in some batches have a design flaw that could lead to lower cutting performance. This may affect the kit's effectiveness during medical procedures.
The drill bits in some batches have a geometrical detail that doesn't match the intended design. This could cause the bits to perform less effectively during medical procedures, potentially leading to lower cutting performance.
Orthofix ankle sterile kits used by medical professionals are affected. Patients receiving these kits during procedures may be at risk if the drill bits don't cut properly.
Check for the UDI number (01)18033509859922 on the kit. Also look for lot numbers B1200695 or B1224714 on the packaging.
Verify the UDI number (01)18033509859922 and lot numbers B1200695 or B1224714 on the ankle sterile kit.
The drill bits in some batches have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance.
Check for the UDI number (01)18033509859922 and lot numbers B1200695 or B1224714 on the ankle sterile kit.
The recall record does not specify a remedy, so no action is required beyond checking the kit details.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0400-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0400-2020 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.
