Orthofix recalls sterile CC plates for fracture repair due to locking screws not engaging properly during surgery. Affected models include Small (002-G-01020), Medium (002-G-01025), and Large (002-G-01030).
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 CC plates used in fracture repair because locking screws may not engage properly during surgery. This could lead to improper fixation of bones and potential complications if the plates are used without proper engagement.
The locking screws may not properly engage with the plates during surgery, which could result in improper bone fixation. This might cause the plates to shift or fail after surgery, potentially leading to complications.
Orthofix CC plates are used by medical professionals for fracture repair. Patients who have received these plates during surgery are at risk if the locking screws fail to engage properly.
Check for the brand 'Orthofix' on the label. Affected models include Small (002-G-01020), Medium (002-G-01025), and Large (002-G-01030). The UDI/Lot numbers are listed as (18056099647694) B1099067 for Small, (18056099647700) B1099061 for Medium, and (18056099647717) B1099063 for Large.
Look for the model numbers on the label: Small (002-G-01020), Medium (002-G-01025), or Large (002-G-01030).
The recall is due to locking screws not properly engaging with the plates during surgery, which could lead to improper bone fixation.
Check the product label for the model numbers. If you have the affected models, contact Orthofix for guidance.
The product may not engage properly during surgery, which could cause improper bone fixation and potential complications.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2126-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2126-2018 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.
