Orthofix recalls specific locking screws used in fracture plating systems due to improper engagement with plates during surgery. Affected items include various sizes and lot numbers. 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 locking screws used in fracture plating systems because they may not properly engage with the plates during surgery. This could lead to complications if the screws fail to hold the plates securely.
The locking screws may not properly engage with the plates during surgery, which could cause the implant to become loose or fail. This might lead to complications such as improper fracture healing or the need for additional surgery.
Medical professionals who use Orthofix Rival Reduce Fracture Plating System or Rival View Plating System implants are most at risk. Patients who have received these implants with the recalled screws should contact Orthofix.
Check for the part numbers listed in the recall: D 2.0MM X 8MM to D 2.0MM X 30MM. Look for the lot numbers and UDI codes provided in the recall notice. The product is labeled as 'Orthofix S.r.r. Italy' on the packaging.
Identify the specific part number and lot numbers listed in the recall notice to confirm if your screws are affected.
Reach out to Orthofix directly for guidance on whether your screws are affected and what steps to take next.
The recall includes locking screws with sizes D 2.0MM X 8MM to D 2.0MM X 30MM, each with specific part numbers and lot numbers listed in the notice.
The screws may not properly engage with the plates during surgery, which could lead to complications such as improper fracture healing or the need for additional surgery.
No, but you should check if your screws are affected and contact Orthofix for guidance. The recall does not require immediate discontinuation but requires verification.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2120-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2120-2018 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.
