Events

Recall of Device Recall CollaGuide Collagen Dental Membrane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kensey Nash Corp.

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
    61819
  • Event Risk Class
    Class 2
  • Event Number
    Z-1621-2012
  • Event Initiated Date
    2012-02-28
  • Event Date Posted
    2012-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109171
  • 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
    Barrier, animal source, intraoral - Product Code NPL
  • Reason
    Recall has been initiated due to concerns regarding the sterility of the product. the firm initiated the recall because of use of inadequately sterilized product might result in patient infection,.
  • Action
    Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.

Device

Device Recall CollaGuide Collagen Dental Membrane
  • Model / Serial
    15mm X 20mm Part Number 20650-01 Lot # 88519 Expiration date 03/31/12  Lot # 92008 Expiration date 09/30/12 Lot # 92067 Expiration date 09/30/12 Lot # 92338 Expiration date 10/31/12 Lot # 94764 Expiration date 03/31/13 Lot # 95275 Expiration date 05/31/13 Lot # 95910 Expiration date 05/31/13 Lot # 97039 Expiration date 08/31/13 Lot # 98318 Expiration date 11/30/13 Lot # 98343 Expiration date 12/31/13 Lot # 84504 Expired Lot # 85270 Expired Lot # 88165 Expired
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. || Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only || 15mm X 20mm || Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. || CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

Kensey Nash Corp
  • Manufacturer Address
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341
  • Manufacturer Parent Company (2017)
    Royal DSM NV
  • Source
    USFDA