Device recall

Z-0701-2020: Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and…

FDA device recall · Class III · Allergan PLC

Key facts

Recall number (Z-number) Z-0701-2020
Recall event 84318
Product Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira…
Product code FTR
Recalling firm Allergan PLC
Recall class Class III
Status Terminated
Termination date Jul 9, 2021
PMA numbers P020056
FEI number 2011068

At a glance

  • None 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)