Orthofix recalls sterile surgical kits with drill bits that may not cut properly due to design flaws. Affected kits have specific catalog numbers and lot codes. Contact Orthofix for details.
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 sterile surgical kits for lower limb procedures because some drill bits may not cut properly due to a design flaw. This could lead to longer surgery times or other complications during the procedure.
The drill bits in the recalled kits have a geometrical detail that doesn't match the intended design. This could cause lower cutting performance, potentially leading to longer surgery times or other complications during the procedure.
Surgical patients and healthcare providers using Orthofix lower limb diaphyseal sterile kits with the specific catalog number and lot codes listed. Patients undergoing surgery with these kits are most at risk.
Check for the catalog number 99-93502JP and lot numbers B1202062, B1224660, B1227924, or B1231700 on the kit's packaging or label. These kits are for surgical use only and require a prescription.
Look for the catalog number 99-93502JP and lot numbers B1202062, B1224660, B1227924, or B1231700 on the kit's packaging or label.
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.
Check the kit's packaging for the catalog number 99-93502JP and lot numbers B1202062, B1224660, B1227924, or B1231700. If you have these, contact Orthofix for further instructions.
The recall states that the drill bits may have lower cutting performance, but there is no mention of serious injury risks. This is a low-risk issue.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0398-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0398-2020 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.
