Orthofix recalls specific non-locking screws used in fracture plates due to failure to properly engage during surgery. Affected models include various sizes with part numbers starting with 002-D-27008.
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 non-locking screws used in fracture plate systems because they may not properly engage with the plates during surgery. This could lead to improper fracture fixation and potential complications for patients.
The screws may not properly engage with the fracture plates during surgical procedures. This could result in the plates not staying securely in place, potentially causing improper fracture fixation and complications for patients.
Patients who received these specific non-locking screws during surgery are affected. Surgeons and medical facilities using the recalled screws are at risk of improper fracture fixation.
Check for screws labeled with size D 2.7MM X 8MM to 40MM (part numbers starting with 002-D-27008 through 002-D-27040). The product includes a unique identifier (UDI) lot number listed in the recall notice.
Look for the size and part numbers listed in the recall notice to confirm if your screws are affected.
Orthofix confirmed that the locking screws do not properly engage with the plates during surgery, which could lead to improper fracture fixation.
The recalled screws are non-locking screws with sizes from D 2.7MM X 8MM to D 2.7MM X 40MM, identified by part numbers starting with 002-D-27008 through 002-D-27040.
The recall notice does not specify a remedy, so no action is required unless you are a medical professional using these screws in surgery.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2121-2018 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.
