Events

Recall of Device Recall ZCORE Syringe

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
    73208
  • Event Risk Class
    Class 3
  • Event Number
    Z-1173-2016
  • Event Initiated Date
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143568
  • 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
    The distributor, osteogenics biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
  • Action
    Collagen Matrix Inc. notified their sole customer on 11/17/2015.

Device

Device Recall ZCORE Syringe
  • Model / Serial
    PMCS025   Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A1   PMCS10  Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A2    PMCS10 Lot No. PMCSU15A2
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US in the state of TX
  • Product Description
    ZCORE Porcine Xenograft Particulate in Syringe || Product Intended for use in dental surgery such as: || -Augmentation or reconstructive treatment of alveolar ridge || -filling of defects after root resection, apicoectomy and cystectomy || -Filling of extraction sockets to enhance preservation of the alveolar ridge || -elevation of maxillary sinus floor || -Filling of periodontal defects in conjunction with products || -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) || -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
  • 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