Device recall

Z-0686-2016: Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile…

FDA device recall · Class II · Abeon Medical Corporation

Key facts

Recall number (Z-number) Z-0686-2016
Recall event 72836
Product Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Product code KNT
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
  • 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

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