Orthofix recalls specific Rival Reduce fracture plating screws due to improper surgical engagement during procedures. Affected items have unique identifiers; contact Orthofix for replacement.
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 certain Rival Reduce fracture plating screws because they don't properly lock during surgery. This could lead to improper fracture fixation if used in medical procedures.
The locking screws fail to securely attach to the plates during surgical procedures. This could cause the fracture to shift or become unstable after surgery, potentially requiring additional interventions.
Medical professionals using the Rival Reduce Fracture Plating System for surgery are most at risk. Patients receiving these screws as part of their treatment may also be affected.
Check for the product name 'Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only' on the label. Look for part numbers 000-K-011C or UDI codes 18056099648592, B1115657, B1107222, B1107223.
Look for the product name and part numbers listed in the recall notice.
The locking screws were confirmed to not properly engage the plates during surgery, which could lead to improper fracture fixation.
The recall notice does not specify a remedy; contact Orthofix directly for guidance.
Check for the product name and part 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-2116-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2116-2018 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.
