Orthofix recalls Prefix II Diaphyseal Complete Kit (Sterile No Screws) due to drill bits with lower cutting performance. Affected units sold outside US; no remedy specified.
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 surgical kit for hip replacements because some drill bits may not cut properly. This could lead to longer surgery times or complications during the procedure.
The drill bits in the kit have a design flaw that reduces their cutting efficiency. This could cause the surgery to take longer or lead to complications during the procedure.
Surgical patients and their healthcare providers who received the recalled kit. Patients using the kit for hip replacement surgery are most at risk.
Check for the catalog number 99-92502 on the kit. The kit includes a unique identifier (UDI) starting with 01 and was sold outside the US. Lot number B1209789 is associated with this recall.
Look for the catalog number 99-92502 and unique identifier starting with 01 on the kit.
No, the product is not marketed in the US.
The recall record does not specify a remedy.
The recall states lower cutting performance, but no serious injury risk is mentioned.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-0391-2020 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-0391-2020 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.
