Repose Bone Screw System

• 2 recalls, same reason

  • Terminated Z-0535-2010 FDA Unclassified (pre-2012) ·initiated 27 Jul 2009
  • Terminated Z-0536-2010 FDA Unclassified (pre-2012) ·initiated 27 Jul 2009

  Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.

510(k) Number

K981677 ↗

FDA Product Code

LRK

Device Class

Class II

Regulation

21 CFR Part 872.5570

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Microtac-Bone Anchor System

  Class II

  FDA 510(k) K990160 Active Cleared 16 Feb 1999

• In-Sling

  Class II

  FDA 510(k) K972651 Active Cleared 19 Sep 1997

• Triangle Sling

  Class II

  FDA 510(k) K980482 Active Cleared 27 Mar 1998

• Influence Clip System

  Class II

  FDA 510(k) K981631 Active Cleared 28 Jul 1998

• Stapletac Bone Anchor System

  Class II

  FDA 510(k) K992277 Active Cleared 30 Jul 1999

• In-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw

  Class II

  FDA 510(k) K970292 Active Cleared 23 Apr 1997

See all devices from Influence, Inc. →