Recall of Device Recall NuOss XC Sinus

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
    73206
  • Event Risk Class
    Class 2
  • Event Number
    Z-1097-2016
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2016-03-11
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
  • 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
    During the 36 month real time shelf life testing of nuoss xc sinus (bmcu-umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
  • Action
    The firm, Collagen Matrix Inc., sent an email dated May 14, 2013 to its sole customer. The email described the product, problem and actions to be taken. The customer was instructed to return all product with expiration dates 12/2014 or earlier under Returned Goods, the firm will replace these products with new inventory; and return to Collagen Matrix, Inc., 15 Thornton Road, Oakland, NJ 07436 or quarantine products with expiration date 1/2016 until further notice. If you have any questions,call 201-405-1477 x 304 or email: www.collagenmatrix.com.

Device

  • Model / Serial
    Lot BMCXU11P1. BMCXU11H3  Lot BMCXU11P1, BMCXU12P1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to state of: MA.
  • Product Description
    NuOss XC Sinus || Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) || Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) || Manufacturer:- Collagen Matrix, || Distributor:- ACE Surgical Supply Co, Inc, || Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -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 intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
  • Manufacturer

Manufacturer

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