Orthofix recalls specific straight plate models due to locking screws failing to engage during surgery. Affected items have unique part numbers and UDI lots. Consumers should 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 straight plate models used in surgery because the locking screws may not properly engage with the plates during surgical procedures. This could lead to improper fixation of bones and potential complications if the plates are used without the screws securely locking.
The locking screws in the recalled straight plates may not properly engage with the plates during surgery. This could result in the plates not staying securely in place, potentially causing bone fractures to not be properly fixed.
Surgical patients who received the recalled straight plate models during surgery are most at risk. Orthofix is the manufacturer of these medical devices.
Check the product label for part numbers: 3-hole (003-D-01001), 4-hole (003-D-02001), or 6-hole (003-D-03001). Also look for the UDI lot numbers listed in the recall notice.
Reach out to Orthofix directly for specific details about your product and instructions on what to do next.
The locking screws may not properly engage with the plates during surgery, which could lead to improper bone fixation.
The affected part numbers are 3-hole (003-D-01001), 4-hole (003-D-02001), and 6-hole (003-D-03001).
Check the product label for the part numbers listed above and the UDI lot numbers provided in the recall notice.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2132-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2132-2018 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.
