Device recall

Z-0684-2016: TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS…

FDA device recall · Class II · Abeon Medical Corporation

Key facts

Recall number (Z-number) Z-0684-2016
Recall event 72836
Product TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Product code FFO
Recalling firm Abeon Medical Corporation
Recall class Class II
Status Terminated
Termination date Oct 27, 2016
FEI number 3008657512

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

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