Orthofix recalls specific lower limb diaphyseal sterile kits due to drill bits with design flaws that may cause lower cutting performance. Affected kits have unique lot numbers and require verification.
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 lower limb diaphyseal sterile kits because some drill bits have a design flaw that could lead to reduced cutting performance. This affects medical procedures requiring precise bone drilling.
The drill bits in the recalled kits have a geometrical detail that doesn't match the intended design. This could cause the bits to perform less effectively when cutting bone during surgery, potentially leading to longer procedures or complications.
Patients undergoing orthopedic surgery who use the recalled kits are affected. Surgeons and medical staff using the specific lot numbers are most at risk.
Check the kit's unique identifier (UDI) code (01)18033509859915 and lot numbers: B1200709, B1204115, B1206439, B1225414, B1233729. The kits are labeled as 'LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY' in the Orthofix catalogue.
Check the kit's unique identifier (UDI) code (01)18033509859915 and lot numbers listed in the recall notice.
The drill bits in the recalled kits have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance during surgery.
Check the kit's unique identifier (UDI) code (01)18033509859915 and lot numbers: B1200709, B1204115, B1206439, B1225414, B1233729.
The recall notice 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-0397-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0397-2020 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.
