Orthofix recalls sterile MTP plates for potential improper screw engagement 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 sterile MTP plates that may not lock properly during surgery. This could lead to improper fracture fixation if used without the correct screw engagement.
The locking screws may not properly engage the plates during surgery, which could result in improper fracture fixation. This might cause the plate to fail under stress, potentially leading to complications.
Orthofix MTP plates used in surgical procedures for fracture reduction. Surgeons and medical facilities that have installed these plates are most at risk.
Check for the label 'MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with part numbers: Small (002-B-01001), Medium (002-B-02002), or Large (002-B-03003). Also look for UDI lots listed in the description.
Reach out to Orthofix directly for specific instructions on handling affected plates.
The locking screws may not properly engage the plates during surgery, which could lead to improper fracture fixation.
Small (002-B-01001), Medium (002-B-02002), and Large (002-B-03003).
Check the label for 'MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy' with the specific part numbers listed in the recall.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2131-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2131-2018 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.
