Class 2 Device Recall CollaGuide Collagen Dental Membrane

• Date Initiated by Firm: February 28, 2012
• Date Posted: May 17, 2012
• Recall Status: Terminated on April 11, 2013
• Recall Number: Z-1621-2012
• 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 15mm X 20mm Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) 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: 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
• Recalling Firm/ Manufacturer: Kensey Nash Corp; 735 Pennsylvania Dr; Exton PA 19341
• For Additional Information Contact: Clinical Affairs Hotline; 484-713-2197
• 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: 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 20650-01 - 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