Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution

• 8 recalls, same reason

  • Terminated Z-0027-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0026-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0030-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0023-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0025-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0029-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0028-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005
  • Terminated Z-0024-06 FDA Unclassified (pre-2012) ·initiated 23 Aug 2005

  The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

510(k) Number

K031449 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• The Trabecular Metal Technology Acetabular Augment System, Models 4893-Xx-Yy (Zimmer), 02-212-05XX1 ( Implex)

  Class II

  FDA 510(k) K012507 Active Cleared 30 Aug 2001

• Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1

  Class II

  FDA 510(k) K051196 Active Cleared 17 Jun 2005

• Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

  Class II

  FDA 510(k) K022563 Active Cleared 30 Aug 2002

• Implex Continuum Porous Patellar

  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

• Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

  Class II

  FDA 510(k) K980486 Active Cleared 14 Apr 1998

• Hedrocel Acetabular Restrictor

  Class II

  FDA 510(k) K962468 Active Cleared 3 Feb 1997

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