Natural-Knee II System

• • Terminated Z-1033-2018 FDA Class II ·initiated 29 Nov 2017

  The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

• • Terminated Z-0839-2016 FDA Class II ·initiated 11 Jan 2016

  LDPE bag containing the implant adheres to the highly polished implant surface.

• 2 recalls, same reason

  • Terminated Z-1262-2014 FDA Class II ·initiated 25 Feb 2014
  • Terminated Z-1249-2014 FDA Class II ·initiated 25 Feb 2014

  A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

• 2 recalls, same reason

  • Terminated Z-0078-2014 FDA Class II ·initiated 30 Aug 2013
  • Terminated Z-0075-2014 FDA Class II ·initiated 30 Aug 2013

  The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

510(k) Number

K936159 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

• Intermedics Power Broach Impactor

  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

• Ioi Bipolar Prosthesis

  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

• Select(R) Shoulder All Poly Glenoid

  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

See all devices from Intermedics Orthopedics →