Orthofix recalls specific 3.2mm drill bits due to design flaws causing reduced cutting performance. Affected units have unique lot numbers and catalog codes. Consumers should check their product details to determine if they are impacted.
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 3.2mm drill bits that may have design flaws leading to lower cutting performance. This could affect the effectiveness of these bits in medical procedures where precision is critical.
The drill bits have a geometrical detail that doesn't match the intended design. This could cause reduced cutting performance, which might affect surgical precision. However, the recall does not mention risks of injury or serious harm.
Medical professionals using these drill bits for surgical procedures are most likely affected. Patients receiving these bits during surgery may be impacted if the bits don't perform as intended.
Check for the catalog number ref 1-1100301 on the drill bit packaging. Look for lot numbers: B1203608, B1210965, B1211752, B1214172, B1218793, 300241, 300240, 273169.
Identify the catalog number and lot numbers on the drill bit to confirm if it is affected.
The recall states these bits may have reduced cutting performance but does not mention safety risks. They are still intended for medical use.
The recall does not specify a remedy, so you should check the product details to see if you have an affected unit.
Look for the catalog number ref 1-1100301 and lot numbers: B1203608, B1210965, B1211752, B1214172, B1218793, 300241, 300240, 273169.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0382-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0382-2020 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.
