Device recall

Z-1984-2025: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone…

FDA device recall · Class II · Chamberlain Technologies LLC

Key facts

Recall number (Z-number) Z-1984-2025
Recall event 96930
Product SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Product code FTL
Recalling firm Chamberlain Technologies LLC
Recall class Class II
Status Completed
510(k) numbers K072974
FEI number 3015860534

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

Browse all FDA device recalls (products)