Orthofix recalls specific locking screws used in fracture plating systems due to improper engagement during surgery. Affected models include sizes 3.2mm x 10mm to 3.2mm x 50mm with certain 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 locking screws used in fracture plating systems because they may not properly engage with the plates during surgery. This could lead to improper fixation of bones, potentially causing complications after the procedure.
The locking screws were confirmed to not properly engage the plates during surgery. This means the screws might not hold the bone plates securely, which could lead to improper fracture fixation and potential complications after the procedure.
Patients who received these specific locking screws during surgery are affected. Surgeons and medical staff using the recalled screws for procedures are at risk of improper bone fixation.
Check the label for 'Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with sizes ranging from 3.2mm x 10mm to 3.2mm x 50mm. The part numbers listed include 002-E-32010 through 002-E-32050 and specific UDI/lot numbers.
Inform your surgeon about the specific locking screws used in your procedure to determine if they are affected by this recall.
The recall states that the screws may not properly engage the plates during surgery, so they are not safe for use in procedures.
Contact your surgeon to determine if you received the recalled screws and follow their instructions for next steps.
Check the label for the specific part numbers (002-E-32010 to 002-E-32050) and UDI/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-2124-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2124-2018 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.
