Device recall

Z-0699-2020: Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style…

FDA device recall · Class III · Allergan PLC

Key facts

Recall number (Z-number) Z-0699-2020
Recall event 84318
Product Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537…
Product code FWM
Recalling firm Allergan PLC
Recall class Class III
Status Terminated
Termination date Jul 9, 2021
PMA numbers P990074
FEI number 2011068

At a glance

  • None Linked 510(k)s
  • 1–9 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)