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U.S. Department of Health and Human Services

Class 2 Device Recall CollaGuide Collagen Dental Membrane

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  Class 2 Device Recall CollaGuide Collagen Dental Membrane see related information
Date Initiated by Firm February 28, 2012
Date Posted May 17, 2012
Recall Status1 Terminated 3 on April 11, 2013
Recall Number Z-1622-2012
Recall Event ID 61819
510(K)Number K090919  
Product Classification Barrier, animal source, intraoral - Product Code NPL
Product 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

20mm X 30mm REF 20650-02 6280-02 Rev.AE

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.
Code Information 20mm X 30mm Part number 20650-02 Lot # 91025 Expiration date 07/31/12 Lot # 92339 Expiration date 10/31/12 Lot # 94765 Expiration date 03/31/13 Lot # 95276 Expiration date 05/31/13 Lot # 95911 Expiration date 05/31/13 Lot # 97040 Expiration date 08/31/13 Lot # 98319 Expiration date 11/30/13 Lot # 84505 Expired Lot # 85271 Expired Lot # 89495 Expired Lot # 89542 Expired 
Recalling Firm/
Kensey Nash Corp
735 Pennsylvania Dr
Exton PA 19341
For Additional Information Contact Clinical Affairs Hotline
Manufacturer Reason
for Recall
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,
FDA Determined
Cause 2
Employee error
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.
Quantity in Commerce Total all sizes - 6387 units; p/n 20650-02 - 1487 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPL and Original Applicant = KENSEY NASH CORP.