Device recall

Z-0576-2007: AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection…

FDA device recall · Class III · Medtronic Xomed, Inc.

Key facts

Recall number (Z-number) Z-0576-2007
Recall event 37298
Product AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.
Product code GZX
Recalling firm Medtronic Xomed, Inc.
Recall class Class III
Status Terminated
Termination date Jul 7, 2012
510(k) numbers K990793
FEI number 1045254

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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