Orthofix recalls specific locking screws used in fracture plates due to improper engagement with surgical plates during procedures. Affected models include sizes 2.7mm x 8mm to 40mm with certain lot numbers.
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 locking screws used in fracture plate systems because they may not properly engage with surgical plates during surgery. This could lead to improper fixation of bones and potential complications for patients.
The locking screws were found not to properly engage with the plates during surgery. This could result in improper bone fixation, potentially causing the fracture to not heal correctly or requiring additional surgery.
Patients who received these specific locking screws during surgery are most at risk. Orthofix is a medical device manufacturer that sells these screws to hospitals and surgical teams.
Check the label for Orthofix S.r.r. Italy on the packaging. The screws have specific sizes (2.7mm x 8mm to 40mm) and lot numbers listed in the recall notice.
Your surgeon can confirm if you received the affected locking screws during surgery and advise on next steps.
The recall is for screws that may not properly engage with plates during surgery, not for normal use outside of surgical procedures.
Check the label for Orthofix S.r.r. Italy on the packaging and look for the specific sizes (2.7mm x 8mm to 40mm) and lot numbers listed in the recall notice.
The recall does not require immediate removal; contact your surgeon to determine if the screws were used in your surgery and what action is needed.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2122-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2122-2018 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.
