Omega II Modular Total Hip System

• • Terminated Z-1868-2008 FDA Unclassified (pre-2012) ·initiated 8 May 2008

  Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.

• 2 recalls, same reason

  • Terminated Z-1066-2007 FDA Unclassified (pre-2012) ·initiated 12 Apr 2007
  • Terminated Z-1065-2007 FDA Unclassified (pre-2012) ·initiated 12 Apr 2007

  Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.

• 2 recalls, same reason

  • Terminated Z-1064-2007 FDA Unclassified (pre-2012) ·initiated 12 Apr 2007
  • Terminated Z-1063-2007 FDA Unclassified (pre-2012) ·initiated 12 Apr 2007

  Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.

510(k) Number

K000817 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Omega Ha Coated Total Hip System

  Class II

  FDA 510(k) K980981 Active Cleared 20 May 1998

• Omega Total Hip System for Cemented Applications

  Class II

  FDA 510(k) K960647 Active Cleared 17 Sep 1996

• OTI Modular Shoulder System

  Class II

  FDA 510(k) K982886 Active Cleared 5 Oct 1998

• Omega Total Hip System for Use Without Bone Cement (Line Extension)

  Class II

  FDA 510(k) K964924 Active Cleared 7 Mar 1997

• Triad II Modular Total Hip System

  Class II

  FDA 510(k) K003199 Active Cleared 10 Jan 2001

• Omega II Modular Total Hip System

  Class II

  FDA 510(k) K984227 Active Cleared 8 Apr 1999

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