Events

Recall of Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Matrix Surgical Holdings, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76356
  • Event Risk Class
    Class 2
  • Event Number
    Z-1382-2017
  • Event Initiated Date
    2017-01-25
  • Event Date Posted
    2017-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152960
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
  • Reason
    Mislabeling. the packaging labeled as left mandible contained a right mandible.
  • Action
    Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.

Device

Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlay
  • Model / Serial
    OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
  • Product Description
    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
  • Manufacturer
    Matrix Surgical Holdings, LLC

Manufacturer

Matrix Surgical Holdings, LLC
  • Manufacturer Address
    Matrix Surgical Holdings, LLC, 4025 Welcome All Rd Sw Ste 120, Atlanta GA 30349-1876
  • Manufacturer Parent Company (2017)
    Matrix Surgical Holdings Llc
  • Source
    USFDA