Orthofix recalls specific surgical screw kits due to improper engagement during surgery. Affected kits may not lock correctly, risking complications. Contact Orthofix for details.
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Orthofix is recalling certain surgical screw kits because they don't lock properly during surgery. This could lead to complications if the screws fail to hold the bone plates securely.
The locking screws were confirmed to not properly engage the plates during surgery. This means the screws might not hold the bone plates securely, potentially causing complications during the procedure.
Surgical patients who received the recalled screw kits during procedures. Surgeons and medical staff using these kits are most at risk.
Check for the model name 'Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only' with the part number 000-K-009C. The kit was sold with lot numbers B1094193, B1104809, or B1107372.
Identify the part number and lot numbers listed in the recall notice to confirm if your kit is affected.
The locking screws were confirmed to not properly engage the plates during surgery, which could lead to complications.
The recall notice does not specify a remedy, so contact Orthofix directly for guidance.
Check for the part number 000-K-009C and lot numbers B1094193, B1104809, or B1107372 on the kit label.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2117-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2117-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
