Interax Total Knee System

• 8 recalls, same reason

  • Terminated Z-0853-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0851-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0856-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0857-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0854-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0852-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0858-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003
  • Terminated Z-0855-03 FDA Unclassified (pre-2012) ·initiated 23 Jan 2003

  The device is demonstrating early wear and delamination.

510(k) Number

K973121 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Naso-Gard Nasogastric Tube Holder

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• Class of Casting Alloys Type III or Alt

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• Howmedica Zirconia Ceramic Femoral Head

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• Extended Balljoint Grip

  Class II

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See all devices from Howmedica Corp. →