Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm

• 9 recalls, same reason

  • Terminated Z-0921-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0917-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0926-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0927-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0925-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0920-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0924-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0922-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0923-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007

  Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

• 2 recalls, same reason

  • Terminated Z-0918-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007
  • Terminated Z-0919-2008 FDA Unclassified (pre-2012) ·initiated 15 Nov 2007

  Curvature Discrepancy --The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

• 2 recalls, same reason

  • Terminated Z-0588-03 FDA Unclassified (pre-2012) ·initiated 7 Jan 2003
  • Terminated Z-0587-03 FDA Unclassified (pre-2012) ·initiated 7 Jan 2003

  Some components have disassociated post-operatively resulting in additional surgery to the patient.

510(k) Number

K952970 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

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