Device recall

Z-3102-2011: OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are…

FDA device recall · Class II · Olympus America Inc.

Key facts

Recall number (Z-number) Z-3102-2011
Recall event 57590
Product OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.
Product code EZO
Recalling firm Olympus America Inc.
Recall class Class II
Status Terminated
Termination date Sep 28, 2012
510(k) numbers K904939
FEI number 2429304

At a glance

  • 1–9 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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