Darwin Knee System (TC3)

• • Terminated Z-2949-2018 FDA Class II ·initiated 18 Jul 2018

  This unit may be missing the screw/collet Assembly

• 6 recalls, same reason

  • Terminated Z-0401-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830
  • Terminated Z-0399-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830
  • Terminated Z-0397-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830
  • Terminated Z-0398-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830
  • Terminated Z-0396-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830
  • Terminated Z-0400-2008 FDA Unclassified (pre-2012) ·initiated 27 Sep 2007 ·on shared 510(k) K952830

  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.

• • Terminated Z-1369-04 FDA Unclassified (pre-2012) ·initiated 22 Dec 2003

  The collar was incorrectly etched for the R (right) and L (Left) orientation

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

510(k) Number

K952830 ↗

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

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  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Adaptalite* Porcelain Veneer Cementation System

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• Fotofill Activator Light

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  Class II

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