Mcghan Magna-Site(Tm) Tissue Expander

• 3 recalls, same reason

  • Ongoing Z-2457-2019 FDA Class I ·initiated 24 Jul 2019
  • Ongoing Z-2458-2019 FDA Class I ·initiated 24 Jul 2019
  • Ongoing Z-2455-2019 FDA Class I ·initiated 24 Jul 2019

  The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

• • Terminated Z-2103-2015 FDA Class II ·initiated 18 Jun 2015

  Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

510(k) Number

K862203 ↗

FDA Product Code

LCJ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Implant, Eye Sphere

  Class II

  FDA 510(k) K781356 Active Cleared 21 Aug 1978

• Ionotphoretic Applicator

  Class II

  FDA 510(k) K781700 Active Cleared 3 Nov 1978

• Mcghan Tissue Expander

  Unclassified

  FDA 510(k) K843704 Active Cleared 31 Oct 1984

• Mcghan Tissue Expander Fill Kit Open recall

  Unclassified

  FDA 510(k) K853014 Active Cleared 18 Sep 1985

• Otological Ventilation Tubes

  Class II

  FDA 510(k) K780956 Active Cleared 22 Jun 1978

• Mcghan Longterm Mammary Expander/Gel-Saline Design

  Unclassified

  FDA 510(k) K864184 Active Cleared 24 Dec 1986

See all devices from Mcghan Medical Corp. →