AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated
FDA device recall Z-0932-2009 · posted 2009-01-27 · Terminated
Recall details
- Recalling firm
- American Medical Systems
- Reason for recall
- The product size shown on the carton labeling does not match the size on the product inside.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 5
- Distribution
- Nationwide Distribution --- including states of TN and TX.
- Date initiated
- 2008-12-05
- Date posted
- 2009-01-27
- Date terminated
- 2012-06-05
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMS COLLAGEN DERMAL MATRIX (K050445) | American Medical Systems, Inc. | 2005-06-17 |