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 to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.
Recall
- Recall Number
- Z-0932-2009
- Event Number
- 50680
- Firm
- American Medical Systems
- FEI Number
- 1000116179
- Product Code
- FTM
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 5, 2008
- Posted
- January 27, 2009
- Terminated
- June 5, 2012
- Address
- 10700 Bren Rd, W Minnetonka, MN, 55343-9679
Description
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 to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.
The product size shown on the carton labeling does not match the size on the product inside.
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.
Nationwide Distribution --- including states of TN and TX.
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