6.5 Mm Cancellous Bone Screw

• • Terminated Z-0139-2013 FDA Class II ·initiated 28 Sep 2012

  A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on

• • Terminated Z-2146-2012 FDA Class II ·initiated 16 Jul 2012

  One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

510(k) Number

K931665 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

• Press-Fit Flared Shell

  Class II

  FDA 510(k) K960633 Active Cleared 1 Oct 1996

See all devices from Encore Orthopedics, Inc. →