Axiem™ 9735649

• FDA 510(k) K001284 decided 12 Jun 2000 Active
• FDA GUDID UDI-DI 00643169657687 listed 19 Jun 2016 Listed

• 2 recalls, same reason

  • Terminated Z-2317-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2319-2016 FDA Class II ·initiated 18 Jul 2016

  Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

• 25 recalls, same reason

  • Terminated Z-1587-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1581-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1582-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1600-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1584-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1601-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1578-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1580-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1591-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1590-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1595-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1594-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1593-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1596-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1598-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1592-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1589-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1585-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1579-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1602-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1583-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1599-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1588-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1597-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1586-2014 FDA Class II ·initiated 24 Apr 2014

  Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

• • Terminated Z-0718-06 FDA Unclassified (pre-2012) ·initiated 1 Feb 2006

  Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 24 Apr 2014 Recall initiated FDA recalls Z-1579-2014
2. 24 Apr 2014 Recall initiated FDA recalls Z-1602-2014
3. 24 Apr 2014 Recall initiated FDA recalls Z-1583-2014
4. 24 Apr 2014 Recall initiated FDA recalls Z-1599-2014
5. 24 Apr 2014 Recall initiated FDA recalls Z-1588-2014
6. 24 Apr 2014 Recall initiated FDA recalls Z-1597-2014
7. 24 Apr 2014 Recall initiated FDA recalls Z-1586-2014
8. 19 Jun 2016 Listed FDA GUDID 00643169657687
9. 18 Jul 2016 Recall initiated FDA recalls Z-2317-2016
10. 18 Jul 2016 Recall initiated FDA recalls Z-2319-2016

20 earlier events are in the sections above.

Trade name

Axiem™

Generic name

Neurological stereotactic surgery system

Model / reference

9735649

Primary DI / UDI-DI

00643169657687

510(k) Number

K001284 ↗

FDA product code

HAW

GMDN term

Neurological stereotactic surgery system

Device class

Class II

Regulation number

882.4560

GUDID distribution status

In Commercial Distribution

Category: Neurological stereotactic surgery system

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• Non-Invasive Patient Tracker

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  CE/MDR

• Autoguide System

  Class I

  CE/MDR

• Tactile Probe

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• Universal Drill Guides

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See all devices from Medtronic Navigation Inc. →