Css Cannulated Screw System

• 3 recalls, same reason

  • Terminated Z-0467-2011 FDA Unclassified (pre-2012) ·initiated 15 Oct 2010 ·on shared 510(k) K060428
  • Terminated Z-0468-2011 FDA Unclassified (pre-2012) ·initiated 15 Oct 2010 ·on shared 510(k) K060428
  • Terminated Z-0466-2011 FDA Unclassified (pre-2012) ·initiated 15 Oct 2010 ·on shared 510(k) K060428

  The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This

• • Terminated Z-1250-2010 FDA Unclassified (pre-2012) ·initiated 7 Apr 2009

  A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.

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

510(k) Number

K060428 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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