Synthes Titanium Multi-Vector Distractor

• • Terminated Z-1745-2013 FDA Class II ·initiated 31 May 2013

  Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there

• 3 recalls, same reason

  • Terminated Z-0905-2013 FDA Class II ·initiated 11 Jan 2013
  • Terminated Z-0903-2013 FDA Class II ·initiated 11 Jan 2013
  • Terminated Z-0904-2013 FDA Class II ·initiated 11 Jan 2013

  It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

510(k) Number

K010690 ↗

FDA Product Code

DZL

Device Class

Class II

Regulation

21 CFR Part 872.4880

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

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  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

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