Speedlink Transverse Connector

• • Terminated Z-0525-2010 FDA Unclassified (pre-2012) ·initiated 21 Sep 2009

  The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal.

• 7 recalls, same reason

  • Terminated Z-0027-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0026-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0029-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0028-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0033-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0030-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009
  • Terminated Z-0032-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2009

  The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.

510(k) Number

K002082 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Spinal Concepts, Inc. →