Orthofix recalls sterile Rival Reduce Kit Plates (part 000-K-012C) due to surgical screws not properly engaging plates, risking improper fracture fixation during surgery.
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 Rival Reduce Kit Plates (part number 000-K-012C) because surgical screws may not properly lock the plates during fracture repair. This could lead to improper bone fixation and potential complications if the device fails during surgery.
The locking screws in these plates may not securely attach to the plates during surgery. This could cause the plates to become loose or dislodge, potentially leading to improper bone alignment and requiring additional surgical intervention.
Orthofix Rival Reduce Kit Plates are used by medical professionals for fracture repair. Surgeons who have recently used these plates during surgery are most at risk if the screws fail to engage properly.
Check for the part number 000-K-012C on the label. The product was sold with a UDI (Unique Device Identifier) of 18056099648608 and lot number B1107421.
Look for the part number 000-K-012C on the label to confirm if the product is recalled.
Orthofix is recalling these plates because surgical screws may not properly engage the plates during surgery, which could lead to improper fracture fixation.
Check the product label for the part number 000-K-012C. If you have this specific part, contact Orthofix for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2118-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2118-2018 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.
