Orthofix recalls US XCaliber Ankle Complete Kit (RX only) with specific lot numbers due to drill bits that may cause lower cutting performance. Affected users should check their kit's lot number.
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 specific batches of their XCaliber Ankle Complete Kit (RX only) because drill bits in these batches have a design flaw that could lead to reduced cutting performance. This means the kit might not work 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 cutting tasks, potentially affecting surgical outcomes.
Patients with orthopedic ankle surgery using the recalled kit (RX only) are most at risk. The recall applies to specific lot numbers sold in the U.S.
Check the lot number on the kit's packaging: B1201157, B1203789, or B1226060. The product is only for prescription use (RX only) and sold under the Orthofix brand.
Look for the lot numbers B1201157, B1203789, or B1226060 on the product packaging.
The drill bits have a geometrical detail that does not correspond to the intended design, which could result in lower cutting performance.
Lot numbers B1201157, B1203789, and B1226060.
The product is safe for use with the correct lot numbers, but the recalled batches may have reduced cutting performance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0388-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0388-2020 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.
