Orthofix recalls specific elbow sterile kits due to drill bits with lower cutting performance. Affected kits have unique lot numbers and UDI codes. Consumers should check their kit details to determine if recalled.
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 elbow sterile kits because some drill bits in the kits may not cut as intended. This could lead to less effective use of the kit during medical procedures.
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 making the kit less effective during medical procedures.
Medical professionals using Orthofix elbow sterile kits with the specific lot numbers listed in the recall. Patients receiving these kits are not directly affected.
Check for the UDI code (01)18054242511533 and lot numbers B1203702, B1205553, B1209103, B1212944, B1215607, B1219056, or B1212544 on the kit packaging.
Look for the UDI code (01)18054242511533 and the listed lot numbers on the kit packaging to determine if it is recalled.
The drill bits in the recalled kits have a geometrical detail that does not correspond to the intended design, which could result in lower cutting performance.
Check for the UDI code (01)18054242511533 and lot numbers B1203702, B1205553, B1209103, B1212944, B1215607, B1219056, or B1212544 on the kit packaging.
The recall record does not specify a remedy, so contact Orthofix directly for further instructions.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0402-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0402-2020 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.
