Orthofix recalls sterile non-locking screws used in fracture plating systems due to failure to properly engage plates during surgery. Affected models include sizes 3.2mm x 10mm to 3.2mm x 50mm with specific UDI/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 sterile non-locking screws used in fracture plating systems because they may not properly engage the plates during surgery. This could lead to improper fixation of bones, potentially causing complications after surgery.
The screws may not properly engage the plates during surgery, which could lead to improper bone fixation. This might cause the fracture to not heal correctly or require additional surgical intervention.
Patients who received these screws during surgery are most at risk. The recall affects specific sizes and lot numbers used in fracture plating systems.
Check for the brand 'Orthofix' on the label. The product includes specific sizes (3.2mm x 10mm to 3.2mm x 50mm) with unique UDI/lot numbers listed in the recall notice.
Reach out to Orthofix directly to confirm if you have the recalled screws in your surgical records.
The recall is for surgical use only, so patients should not use these screws for any purpose outside of medical procedures.
The affected models are Orthofix non-locking screws with sizes from 3.2mm x 10mm to 3.2mm x 50mm, each with specific UDI/lot numbers listed in the recall notice.
Check the label for 'Orthofix' and look for the specific size and 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-2123-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2123-2018 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.
