Orthofix recalls specific pelvis sterile kits with drill bits that may have lower cutting performance. Affected kits include lot numbers B1200694, B1204116, B1224715, B1232315. Contact Orthofix for remedy.
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 pelvis sterile kits with drill bits that may have lower cutting performance. This could affect surgical procedures where precise cutting is needed. Affected kits have specific lot numbers and were sold with a UDI code.
The drill bits in affected 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 patients and medical professionals using Orthofix pelvis sterile kits with the specified lot numbers. Those most at risk are individuals performing surgeries requiring precise cutting.
Check the kit's UDI code (01)18033509859908 and lot numbers: B1200694, B1204116, B1224715, B1232315. These kits were sold with the specific catalogue number 99-93501.
Identify if your kit has lot numbers B1200694, B1204116, B1224715, or B1232315.
The drill bits in affected kits have a geometrical detail that doesn't match the intended design, which could result in lower cutting performance during surgical procedures.
Check the lot numbers on your kit. If it matches the affected lots, contact Orthofix for further instructions.
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-0394-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0394-2020 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.
