Orthofix recalls specific pelvis sterile kits with drill bits that may have lower cutting performance due to design issues. Affected kits include certain lots sold under catalog number 99-93501JP.
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 pelvis sterile kits that contain drill bits with a design flaw causing lower cutting performance. This could affect surgical procedures where precise cutting is needed.
The drill bits in these kits have a geometrical detail that doesn't match the intended design. This could lead to lower cutting performance during surgical procedures, potentially affecting the precision needed for pelvis surgeries.
Surgical professionals using Orthofix pelvis sterile kits with the specific catalog number 99-93501JP and affected lots. Patients undergoing surgery with these kits may be at slightly higher risk due to potential cutting issues.
Check for the catalog number 99-93501JP on the kit. Look for the specific lots listed: B1202055, B1225324, B1225854, B1226694, B1228037, B1228211, B1228361, B1228547, B1231459.
Verify the catalog number and lot numbers on the kit to confirm if it's affected.
The recall is due to drill bits in specific kits having a geometrical detail that doesn't match the intended design, which could cause lower cutting performance.
Check the catalog number and lot numbers to see if your kit is affected. If it is, contact Orthofix for guidance.
The recall states lower cutting performance, not a risk of serious injury. This is a low-risk issue affecting surgical precision.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0395-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0395-2020 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.
