Orthofix recalls specific batches of XCaliber Metadiaphyseal Complete Kit (RX only) due to drill bits with design flaws that may cause lower cutting performance. Affected units have unique UDI numbers and lot codes listed in the recall.
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 certain batches of XCaliber Metadiaphyseal Complete Kit (RX only) because drill bits in these batches have a design flaw that could lead to lower cutting performance. This means the kit might not function as intended during medical procedures.
The drill bits in the recalled batches have a geometrical detail that doesn't match the intended design. This could cause the bits to perform less effectively during surgical procedures, potentially leading to longer surgery times or incomplete cuts.
Orthofix XCaliber Metadiaphyseal Complete Kit (RX only) users who purchased the specific batches listed in the recall. Medical professionals using the kit for surgical procedures are most at risk due to potential cutting performance issues.
Check for the UDI number (01)18032937169696 and lot codes B1207402, B1209817, B1211407, B1212676, B1229618, B1232423, B1233324, or B1233663 on the kit packaging or documentation.
Verify the UDI number and lot codes listed in the recall to confirm if your kit is affected.
The drill bits in these batches have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance during surgical procedures.
The recall does not specify a remedy, so check the UDI number and lot codes to confirm if your kit is affected. If affected, contact Orthofix for further instructions.
The recall states there is a risk of lower cutting performance, which could lead to longer surgery times or incomplete cuts, but it does not mention serious injury risks.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0387-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0387-2020 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.
