Device recall

Z-0964-2015: MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast…

FDA device recall · Class II · Mentor Texas, LP.

Key facts

Recall number (Z-number) Z-0964-2015
Recall event 70042
Product MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Product code MRD
Recalling firm Mentor Texas, LP.
Recall class Class II
Status Terminated
Termination date Jan 4, 2016
510(k) numbers K062421
FEI number 1000118360

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)