Orthofix recalls sterile T-Plate plates used in surgery due to locking screws failing to engage properly during procedures. 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 sterile T-Plate plates used in surgery because the locking screws may not properly attach to the plates during surgery. This could lead to improper fracture fixation and potential complications for patients.
The locking screws may not properly engage with the plates during surgery, which could result in improper fracture fixation. This might cause the plates to become loose or fail to hold the bone fragments together.
Patients who received these T-Plates during surgery are most at risk. Medical professionals using the product for fracture repair may also be affected.
Check for the label 'T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with part numbers 003-B-01001 (small) or 003-B-02001 (large). The UDI/lot numbers are 18056099647762 (B1098805) or 18056099647779 (B1102020).
Reach out to Orthofix directly to confirm if your specific T-Plate model is affected and get instructions for next steps.
The locking screws may not properly engage with the plates during surgery, which could lead to improper fracture fixation.
Small: 003-B-01001; Large: 003-B-02001.
Look for the label 'T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with the specific part numbers 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-2134-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2134-2018 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.
