Z-1623-2012

a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide...

Name: Z-1623-2012 a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide...
Creator: Kensey Nash Corp
Published: 2012-02-28
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2012-02-28 / Terminated / root cause: manufacturing process

FDA source

Kensey Nash Corp began a recall of a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box... on 2012-02-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1623-2012
Status: Terminated
Initiated: 2012-02-28
Posted: 2012-05-17
Terminated: 2013-04-11
Recalling firm: DSM Biomedical, Inc.
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 30mm X 40mm REF 20650-03 6280-03 Rev.AE 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.
Product code: NPL Barrier, Animal Source, Intraoral
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,
Root cause tag: manufacturing process
FDA root 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 20650-03 - 765 units
Distribution: Worldwide Distribution.
Product codes and lots: 30mm X 40mm Part number 20650-03 Lot # 91026 Expiration date 07/31/12 Lot # 92340 Expiration date 10/31/12 Lot # 94766 Expiration date 03/31/13 Lot # 95912 Expiration date 05/31/13 Lot # 97041 Expiration date 08/31/13 Lot # 98321 Expiration date 11/30/13 Lot # 84506 Expired Lot # 86568 Expired Lot # 89496 Expired

Product code NPL

K090919Class IIKensey Nash Fibrillar Collagen Dental MembraneKensey Nash Corp. / cleared 2009-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)