Orthofix recalls Prefix II Diaphyseal Complete Kit (Sterile Long Screws) due to drill bits with design flaws that may cause lower cutting performance. Affected units sold outside the US.
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 surgical kit for lower cutting performance due to drill bit design flaws. This affects patients using the kit under prescription, but the risk is not life-threatening.
The drill bits in the kit have a geometrical detail that doesn't match the intended design. This could lead to reduced cutting efficiency, which might affect surgical precision but does not cause injury or death.
Patients with prescription for this surgical kit are affected. Surgeons and medical staff using the kit are most at risk due to potential performance issues during procedures.
Check for the Orthofix Prefix II Diaphyseal Complete Kit with sterile long screws, catalogue number 99-92503, and lot number B1207287. This product was not marketed in the US.
Verify the catalogue number 99-92503 and lot number B1207287 on the kit packaging.
No, this product was not marketed in the US.
The drill bits have a geometrical detail that does not correspond to the intended design, which may cause lower cutting performance.
No, the recall does not require stopping use; it only addresses potential performance issues.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0392-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0392-2020 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.
