Orthofix recalls Y-Plate surgical plates due to locking screws failing to engage during surgery. Affected items have specific part numbers and UDI lots. 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 Y-Plate surgical plates because locking screws may not properly engage with the plates during surgery. This could lead to improper fracture fixation if used in medical procedures.
The locking screws in the Y-Plate may not securely attach to the plates during surgical procedures. This could result in the plates failing to hold bones together properly after surgery, potentially causing complications.
Medical professionals using the Y-Plate surgical plates for fracture repair are most at risk. Patients receiving these plates as part of their treatment may also be affected.
Check the label for 'Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with part numbers: Small (003-C-01001) or Large (003-C-02001). The UDI/lot numbers are (18056099647786) B1102163 for Small and (18056099647793) B1106912 for Large.
Reach out to Orthofix directly for specific instructions on handling recalled Y-Plate plates.
The recall is due to locking screws not properly engaging with the plates during surgery, which could lead to improper fracture fixation.
Small: 003-C-01001 and Large: 003-C-02001, with specific UDI/lot numbers listed on the label.
The recall record does not specify a stop-use instruction, so consumers should contact Orthofix for guidance.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2135-2018 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.
