Recall Z-0932-2009 ยท FTM Mesh, Surgical
American Medical Systems
AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation
| Date | Jan 27, 2009 (initiated Dec 5, 2008) |
| Status | Terminated |
| Reason | The product size shown on the carton labeling does not match the size on the product inside. |
| Root cause | Labeling mix-ups |
| Action | Customers were first notified by phone on 12/05/08. They were told of the situation and were requested to return the devices. Customers were also provided an Important Product Recall letter, dated 12/05/08. This letter identified affected product, told customers to discontinue use of product and to return it. An acknowledgement form was also asked to be returned. AMS Customer Service should be contacted at 1-800-328-3881 to receive a Return Authorization number and arrange for shipment of replacement product. |
| Quantity | 5 |
| Distribution | Nationwide Distribution --- including states of TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050445 | AMS COLLAGEN DERMAL MATRIX American Medical Systems, Inc., Jun 17, 2005 |