Device recall

Z-1684-2026: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH…

FDA device recall · Class II · Mentor Texas, LP.

Key facts

Recall number (Z-number) Z-1684-2026
Recall event 98482
Product CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Product code LCJ
Recalling firm Mentor Texas, LP.
Recall class Class II
Status Open, Classified
510(k) numbers K241918
FEI number 1000118360

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)