Orthofix recalls specific Fitbone Trochanteric Nails L245mm (D9mm, Sterile) due to potential bending during insertion, requiring replacement. Affected units have lot numbers B4771336 and B4771337.
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Orthofix is recalling Fitbone Trochanteric Nails L245mm (D9mm, Sterile) because they may bend during insertion, requiring replacement. This could lead to needing a new implant after the procedure.
The nails may bend at the distal tail during insertion, which could require replacement. This bending might happen during the surgical procedure and could lead to complications needing additional surgery.
Patients who received the recalled Fitbone Trochanteric Nails L245mm (D9mm, Sterile) during hip surgery are affected. Surgeons and medical staff who used these specific implants are at higher risk.
Check for lot numbers B4771336 or B4771337 on the packaging. The product is a sterile, 245mm long, 9mm diameter trochanteric nail used in hip surgery.
Look for lot numbers B4771336 or B4771337 on the packaging or implant documentation.
The recall is due to the potential that these nails may bend at the distal tail during insertion, requiring replacement.
The official recall notice does not specify a remedy or action for affected users.
Check for lot numbers B4771336 or B4771337 on the packaging or implant documentation.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-1977-2025 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-1977-2025 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.