Device recall

Z-0748-2017: ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5)…

FDA device recall · Class II · Ellman International, Inc.

Key facts

Recall number (Z-number) Z-0748-2017
Recall event 75351
Product ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.
Product code GEI
Recalling firm Ellman International, Inc.
Recall class Class II
Status Terminated
Termination date Jun 18, 2018
510(k) numbers K123366
FEI number 2428235

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

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