Orthofix recalls specific Evans Plate sizes due to locking screws failing to engage plates during surgery. Affected products include 6MM, 8MM, 10MM, and 12MM spacers with certain 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 specific sizes of Evans Plates because the locking screws may not properly engage the plates during surgery. This could lead to improper fracture fixation and potential complications for patients.
The locking screws in the Evans Plate may not properly engage with the plates during surgery. This could result in improper fracture fixation, potentially causing complications for patients.
Patients who received these specific plate sizes during surgery are most at risk. Orthofix is the manufacturer of these medical devices.
Check for the product label indicating 'Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy'. The affected sizes are 6MM (002-H-00006), 8MM (022-H-00008), 10MM (002-H-00010), and 12MM (002-H-00012) with specific lot numbers.
Reach out to Orthofix directly for details about your specific product and next steps.
Orthofix confirmed that the locking screws may not properly engage the plates during surgery, which could lead to improper fracture fixation.
The affected sizes are 6MM (002-H-00006), 8MM (022-H-00008), 10MM (002-H-00010), and 12MM (002-H-00012).
Check the product label for 'Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' and verify the specific size and lot numbers listed 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-2127-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2127-2018 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.
