Darwin Knee System

• • Terminated Z-1077-2014 FDA Class II ·initiated 9 Dec 2013

  Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

• • Terminated Z-1686-2009 FDA Unclassified (pre-2012) ·initiated 7 May 2009

  There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.

• 6 recalls, same reason

  • Terminated Z-0403-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0407-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0402-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0404-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0405-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462
  • Terminated Z-0406-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K943462

  An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K943462 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• P.F.C. Uni-Compartmental Knee System

  Class II

  FDA 510(k) K954481 Active Cleared 10 Oct 1996

• J & J Cardiovascular Maxima Hollow Fiber Oxygenato

  Class II

  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Darwin Knee System (TC3)

  Class II

  FDA 510(k) K952830 Active Cleared 18 Jan 1996

• Adaptalite* Porcelain Veneer Cementation System

  Class II

  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

  Class II

  FDA 510(k) K945585 Active Cleared 26 Oct 1995

• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

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