Device recall

Z-0050-2014: Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and…

FDA device recall · Class II · Convergent Dental

Key facts

Recall number (Z-number) Z-0050-2014
Recall event 66361
Product Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Product code GEX
Recalling firm Convergent Dental
Recall class Class II
Status Terminated
Termination date Nov 15, 2013
510(k) numbers K123494, K130420
FEI number 3010175098

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)