Orthofix recalls specific drill bits (catalog #11007) due to lower cutting performance. Affected items have a geometrical detail mismatch. No remedy specified in official notice.
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 a specific drill bit model (catalog number 11007) because it has a design flaw that causes lower cutting performance. This means the drill bit may not work as intended for medical procedures.
The drill bit has a geometrical detail that doesn't match the intended design. This causes lower cutting performance, which could lead to the bit not functioning correctly during medical procedures.
Medical professionals using the drill bit for surgical procedures are likely affected. Patients receiving the drill bit for medical treatments are at risk if the bit doesn't cut properly.
Check for the catalog number 11007, drill bit diameter 4.8 mm, length 280 mm, labeled as 'RX ONLY' and non-sterile. The unique identifier (UDI) is (01)18032568031959 and lot number B1200908.
Identify if your drill bit has the catalog number 11007, diameter 4.8 mm, length 280 mm, labeled 'RX ONLY' and non-sterile.
The official recall notice does not specify any remedy.
Check for the catalog number 11007, diameter 4.8 mm, length 280 mm, labeled 'RX ONLY' and non-sterile. The unique identifier (UDI) is (01)18032568031959 and lot number B1200908.
The recall does not require stopping use; the issue is a design flaw causing lower cutting performance, not an immediate safety hazard.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0373-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0373-2020 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.
