Device recall

Z-2451-2019: Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube…

FDA device recall · Class I · Allergan PLC

Key facts

Recall number (Z-number) Z-2451-2019
Recall event 83500
Product Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style…
Product code FWM
Recalling firm Allergan PLC
Recall class Class I
Status Open, Classified
PMA numbers P990074
FEI number 2011068

At a glance

  • None Linked 510(k)s
  • 10–99 Products in the same recall event
  • 1–9 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)