Device recall

Z-0702-2020: NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20…

FDA device recall · Class III · Allergan PLC

Key facts

Recall number (Z-number) Z-0702-2020
Recall event 84318
Product NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft…
Product code MRD
Recalling firm Allergan PLC
Recall class Class III
Status Terminated
Termination date Jul 9, 2021
510(k) numbers K831566
FEI number 2011068

At a glance

  • 1–9 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)