Orthofix recalls specific H-Plate spacers due to locking screws failing to engage plates during surgery. Affected units include 12mm, 15mm, 20mm, 25mm, and 30mm spacers manufactured in 2017.
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 H-Plate spacers that may not properly lock during surgery. This could lead to improper fracture fixation if used in medical procedures.
The locking screws in these spacers do not properly engage with the plates during surgical procedures. This could result in the plates not staying securely in place, potentially causing improper fracture fixation.
Orthopedic surgeons and medical facilities using the recalled H-plate spacers for fracture repair are most at risk. Patients receiving these spacers during surgery may face complications.
Check for the H-Plate spacers labeled with size (12mm, 15mm, 20mm, 25mm, or 30mm) and part numbers 003-H-12001 through 003-H-30001. The lot numbers B1096733 to B1100226 were manufactured on November 13, 2017.
Look for the size (12mm, 15mm, 20mm, 25mm, or 30mm) and part numbers 003-H-12001 through 003-H-30001 on the spacer packaging.
The recall is due to locking screws not properly engaging with the plates during surgery, which could lead to improper fracture fixation.
The official recall notice does not specify a remedy or action steps beyond checking the product labels.
The recall indicates a risk of improper surgical fixation, but the official notice does not specify patient safety risks.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2128-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2128-2018 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.
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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.
