Events

Recall of Device Recall Collagen Matrix Inc.

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

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
    73222
  • Event Risk Class
    Class 2
  • Event Number
    Z-1096-2016
  • Event Initiated Date
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143588
  • 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
    Bone grafting material, animal source - Product Code NPM
  • Reason
    On 8/25/2015, collagen matrix, inc discovered that one of the 171 units of nuoss cancellous product shipped to a distributor may have included an incorrect size.
  • Action
    Collagen Matrix Inc. notified their sole customer on November 17, 2015. On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size. For further questions please call (201) 405-1477

Device

Device Recall Collagen Matrix Inc.
  • Model / Serial
    Reference No. BM2C20010-U Lot no. BM2CU15E2
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of : MA
  • Product Description
    NuOSS Cancellous || Intended for use in dental surgery.
  • Manufacturer
    Collagen Matrix Inc

Manufacturer

Collagen Matrix Inc
  • Manufacturer Address
    Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
  • Manufacturer Parent Company (2017)
    Collagen Matrix Inc.
  • Source
    USFDA