Orthofix recalls specific ankle kits with drill bits that may have lower cutting performance due to design issues. Affected units include certain lot numbers from the listed catalogue.
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 ankle 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 have a geometrical detail that doesn't match the intended design, leading to reduced cutting performance. This could impact the precision of surgical procedures requiring accurate cuts.
Orthofix ankle kits used for medical procedures, particularly those with the listed lot numbers. Surgeons and medical facilities using these kits are most at risk.
Check the product label for the catalogue number 99-91647UE and lot numbers B1206515, B1206561, B1209206, B1211406, B1212677, B1215964, or B1233839.
Look for the catalogue number 99-91647UE and the specific lot numbers listed in the recall.
The drill bits have a geometrical detail that does not correspond to the intended design, which could result in lower cutting performance.
Check the product label for the catalogue number 99-91647UE and lot numbers listed in the recall. If you have the affected lot numbers, contact Orthofix for further instructions.
The recall record does not specify a remedy or fix for the drill bits.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0389-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0389-2020 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.
