Device recall

Z-1074-04: AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

FDA device recall · Class II · Encision, Inc.

Key facts

Recall number (Z-number) Z-1074-04
Recall event 29430
Product AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Product code GEI
Recalling firm Encision, Inc.
Recall class Class II
Status Terminated
Termination date Nov 9, 2004
510(k) numbers K912780
FEI number 1000117361

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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