Orthofix recalls specific batches of sterile short screws for orthopedic use due to drill bit design flaws that may cause lower cutting performance. Affected kits include model 99-92501 with lot numbers B1207286, B1207428, B1211384, B1215263.
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 sterile short screws for orthopedic surgery. The drill bits in these kits may not cut properly due to a design flaw, which could lead to surgical complications.
The drill bits have a geometrical detail that doesn't match the intended design. This could result in lower cutting performance during surgery, potentially causing surgical complications if the bits don't function as expected.
Orthopedic surgeons and medical professionals using the recalled kits for surgical procedures. Patients receiving these kits are not directly affected as the issue is with the surgical tools, not the patient.
Check for the Orthofix Catalogue Number 99-92501 with lot numbers B1207286, B1207428, B1211384, or B1215263. These kits are not marketed in the US, so they may not be available for domestic use.
Verify the catalogue number and lot numbers listed in the recall notice to confirm if your kit is affected.
No, the kits are not marketed in the US.
The drill bits may have lower cutting performance, which could lead to surgical complications during procedures.
The recall does not require stopping use; it only identifies specific batches that may have design issues.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0390-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0390-2020 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.
