Device recall

Z-0749-2017: Cellfina Prep Pack, Part No. CP1

FDA device recall · Class II · Ulthera Inc

Key facts

Recall number (Z-number) Z-0749-2017
Recall event 75682
Product Cellfina Prep Pack, Part No. CP1
Product code OUP
Recalling firm Ulthera Inc
Recall class Class II
Status Terminated
Termination date Sep 13, 2017
510(k) numbers K161885
FEI number 1012187

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

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