Device recall

Z-0932-2009: AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm…

FDA device recall · Class III · American Medical Systems

Key facts

Recall number (Z-number) Z-0932-2009
Recall event 50680
Product 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…
Product code FTM
Recalling firm American Medical Systems
Recall class Class III
Status Terminated
Termination date Jun 5, 2012
510(k) numbers K050445
FEI number 1000116179

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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