Orthofix recalls specific sizes of non-locking screws used in fracture plates due to potential failure to engage plates during surgery. Affected products include models with part numbers 0002-D-20008 to 002-D-20030.
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 non-locking screws used in fracture plates because they may not properly lock into the plates during surgery. This could lead to improper fracture fixation and potential complications for patients.
The screws may not engage properly with the plates during surgery, which could result in improper fracture fixation. This might cause the fracture to heal incorrectly or require additional surgical intervention.
Patients who received these specific screw sizes during surgery are most at risk. Medical professionals using these screws for fracture repairs should verify their compatibility.
Check the label for the part number starting with 'D 2.0MM' and sizes from 8mm to 30mm. The product includes specific UDI/lot numbers listed in the recall notice.
Look for the part number starting with 'D 2.0MM' and sizes from 8mm to 30mm on the label.
Reach out to Orthofix directly for guidance on whether your specific screws are affected and next steps.
Yes, these screws are part of the Rival Reduce Fracture Plating System used in fracture repair procedures.
Check the label for part numbers starting with 'D 2.0MM' and sizes from 8mm to 30mm, including the specific UDI/lot numbers listed in the recall notice.
Contact Orthofix directly to determine if your screws are affected and follow their instructions for next steps.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2119-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2119-2018 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.
