The Nexgen Knee System Uncemented Components

• 4 recalls, same reason

  • Terminated Z-1951-2016 FDA Class II ·initiated 15 Apr 2016
  • Terminated Z-1953-2016 FDA Class II ·initiated 15 Apr 2016
  • Terminated Z-1950-2016 FDA Class II ·initiated 15 Apr 2016
  • Terminated Z-1952-2016 FDA Class II ·initiated 15 Apr 2016

  Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

510(k) Number

K031462 ↗

FDA Product Code

MBH

Device Class

Class II

Regulation

21 CFR Part 888.3565

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

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

  Class II

  FDA 510(k) K031449 Active Cleared 23 Sep 2003

• 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

See all devices from Implex Corp. →