Arthrocare Arthrowands

• 12 recalls, same reason

  • Terminated Z-0619-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0616-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011 ·on shared 510(k) K082980
  • Terminated Z-0618-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0623-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0615-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0617-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0626-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0624-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0622-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0621-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0620-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0625-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011

  Product is being removed from the field due to an over-label issue.

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

510(k) Number

K082980 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from ArthroCare Corporation →