Orthofix recalls sterile ankle kits with specific lot numbers due to drill bits that may not cut properly. Affected kits were not marketed in the US.
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 ankle kits with certain lot numbers because the included drill bits may not cut as intended. This could lead to less effective surgical procedures.
The drill bits in these kits have a design flaw that reduces their cutting performance. This could lead to less effective surgical procedures if the bits don't cut properly during the operation.
Orthofix ankle kits with lot numbers B1207288, B1215312, B1228971, or B1233730 are affected. Surgeons and medical professionals using these kits for surgical procedures are most at risk.
Check the lot number on the kit's packaging. Affected kits have lot numbers B1207288, B1215312, B1228971, or B1233730. These kits were not marketed in the US.
Look for lot numbers B1207288, B1215312, B1228971, or B1233730 on the packaging.
No, these kits were not marketed in the US.
Check the lot number on the packaging. If it matches the affected numbers, contact Orthofix for guidance.
The drill bits in these kits have a design flaw that may reduce cutting performance during surgical procedures.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0393-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0393-2020 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.
