Uhr UNIVERSAL6HIP Replacement

• 36 recalls, same reason

  • Terminated Z-0649-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0652-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0650-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0648-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0632-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0628-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0623-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0629-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0645-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0636-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0625-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0621-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0624-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0642-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0638-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0640-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0644-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0635-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0639-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0643-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0654-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0633-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0630-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0646-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0634-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0627-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0655-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0637-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0656-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0651-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0626-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0622-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0631-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0641-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0647-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007
  • Terminated Z-0653-2008 FDA Unclassified (pre-2012) ·initiated 26 Oct 2007

  Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

510(k) Number

K800207 ↗

FDA Product Code

KWL

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →