Orthofix recalls specific Lapidus plates due to locking screws failing to engage during surgery. Affected products include certain sizes and model numbers with UDI/lot codes. 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 specific Lapidus plates that may have locking screws that don't properly engage during surgery. This could lead to improper fracture fixation if used in medical procedures.
The locking screws in these plates may not properly engage with the plates during surgical procedures. This could result in the plates not staying securely in place, potentially causing improper fracture fixation.
Medical professionals using the Lapidus plates for fracture repair are most at risk. Patients receiving these plates as part of their treatment may also be affected.
Check for the product name 'Lapidus Plate, Sterile, Rx Only' with the manufacturer label 'ORTHOFIX S.r.r. Italy'. Look for specific model numbers and UDI/lot codes listed in the recall notice.
Reach out to Orthofix directly to confirm if your specific Lapidus plate model is affected and get instructions on next steps.
The recall indicates that the locking screws may not properly engage during surgery, so affected plates should not be used until the issue is resolved.
Contact Orthofix to determine if your specific model is affected and follow their instructions for next steps.
Check the product label for the model numbers and UDI/lot codes listed in the recall notice to see if they match the affected items.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2129-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2129-2018 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.
