Duracon Total Knee System Tibial Components

• 3 recalls, same reason

  • Ongoing Z-0918-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0916-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0917-2024 FDA Class II ·initiated 1 Dec 2023

  Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

• • Terminated Z-1601-2009 FDA Unclassified (pre-2012) ·initiated 5 May 2006

  A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.

510(k) Number

K915512 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• 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

• Duracon Modular Femoral Component and Femoral Spac

  Class II

  FDA 510(k) K920034 Active Cleared 18 Mar 1992

• 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

• Bondek Polyglycolic Acid Synthetic Absorb. Suture

  Class II

  FDA 510(k) K905482 Active Cleared 14 Mar 1991

See all devices from Pfizer Hospital Products Group, Inc. →