P.F.C.(Tm) Modular Knee System

• • Terminated Z-3099-2011 FDA Unclassified (pre-2012) ·initiated 28 Jun 2011

  DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot, the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella, but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella.

• 15 recalls, same reason

  • Terminated Z-1336-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1345-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1337-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1343-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1333-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1341-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1334-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1338-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1339-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1342-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1344-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1346-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1335-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1332-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005
  • Terminated Z-1340-05 FDA Unclassified (pre-2012) ·initiated 26 May 2005

  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.

510(k) Number

K884796 ↗

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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