Recall Z-1622-2012 ยท NPL Barrier, Animal Source, Intraoral
Kensey Nash Corp
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
| Date | May 17, 2012 (initiated Feb 28, 2012) |
| Status | Terminated |
| 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, |
| 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 | Total all sizes - 6387 units; p/n 20650-02 - 1487 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE Kensey Nash Corp., Oct 2, 2009 |