3D Knee

• • Terminated Z-2244-2010 FDA Unclassified (pre-2012) ·initiated 28 Jun 2010

  One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.

• • Terminated Z-1433-2010 FDA Unclassified (pre-2012) ·initiated 19 Mar 2010

  Affected product had incorrect color label which is a secondary visual indicator for sizing.

• • Terminated Z-1539-2008 FDA Unclassified (pre-2012) ·initiated 20 Feb 2008

  Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.

• • Terminated Z-0332-06 FDA Unclassified (pre-2012) ·initiated 3 Nov 2005

  The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

• • Terminated Z-1011-04 FDA Unclassified (pre-2012) ·initiated 10 May 2004

  Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

510(k) Number

K020114 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →