Orthofix recalls specific batches of sterile radiolucent wrist fixator kits due to drill bits with design flaws that may cause lower cutting performance. Affected units include model ref: 99-36501 with lots B1200654 to B1232424.
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 sterile radiolucent wrist fixator kits because drill bits in these kits have a design flaw that could lead to lower cutting performance. This issue may affect medical procedures requiring precise drilling.
The drill bits in the recalled kits have a geometrical detail that doesn't match the intended design. This could result in lower cutting performance during medical procedures, potentially affecting the precision of the fixator application.
Patients using the recalled radiolucent wrist fixator kits for medical procedures. Healthcare providers who have ordered or used these kits are most at risk.
Check for the model number ref: 99-36501 on the kit packaging. Affected lots include B1200654, B1205554, B1208340, B1215045, B1215995, and B1232424. The kits are sterile and require a prescription.
Verify the model number and lot numbers on the kit packaging to confirm if it is affected.
The recalled model is ref: 99-36501.
Affected lots include B1200654, B1205554, B1208340, B1215045, B1215995, and B1232424.
The drill bits may have lower cutting performance, which could affect the precision of the fixator application during medical procedures.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0386-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0386-2020 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.
