Duracon Modular Femoral Component and Femoral Spac

• • Terminated Z-1241-2007 FDA Unclassified (pre-2012) ·initiated 17 Oct 2006

  Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

• • Terminated Z-0014-2011 FDA Unclassified (pre-2012) ·initiated 5 Oct 2006

  Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.

510(k) Number

K920034 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst

  Class II

  FDA 510(k) K911656 Active Cleared 13 Aug 1991

• Mega Plus Super Lag Screw

  Class II

  FDA 510(k) K930156 Active Cleared 22 Feb 1994

• Schneider Wallstent(R)

  Class II

  FDA 510(k) K911292 Active Cleared 1 May 1991

• Howmedica Alumina Femoral Head

  Class II

  FDA 510(k) K915184 Active Cleared 31 Jan 1992

• Duracon Total Knee System Tibial Components Open recall

  Class II

  FDA 510(k) K915512 Active Cleared 18 Aug 1992

• Bondek Polyglycolic Acid Synthetic Absorb. Suture

  Class II

  FDA 510(k) K905482 Active Cleared 14 Mar 1991

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