Device recall

Z-1235-2008: AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile…

FDA device recall · Class II · American Medical Systems

Key facts

Recall number (Z-number) Z-1235-2008
Recall event 46833
Product AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
Product code MBI
Recalling firm American Medical Systems
Recall class Class II
Status Terminated
Termination date Oct 13, 2010
510(k) numbers K970292
FEI number 1000116179

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)