Device recall

Z-1608-2016: TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS…

FDA device recall · Class II · Applied Medical Technology Inc

Key facts

Recall number (Z-number) Z-1608-2016
Recall event 73318
Product TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Product code GAD
Recalling firm Applied Medical Technology Inc
Recall class Class II
Status Terminated
Termination date Oct 27, 2016
FEI number 1526012

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)