Device recall

Z-1216-03: McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped…

FDA device recall · Class III · Inamed Corp

Key facts

Recall number (Z-number) Z-1216-03
Recall event 27022
Product McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
Product code FWM
Recalling firm Inamed Corp
Recall class Class III
Status Terminated
Termination date Sep 10, 2003
FEI number 2024601

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)