Gyrus Open Forceps

• 6 recalls, same reason

  • Terminated Z-0633-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009
  • Terminated Z-0635-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009
  • Terminated Z-0634-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009
  • Terminated Z-0636-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009
  • Terminated Z-0632-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009
  • Terminated Z-0637-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009

  Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI.

510(k) Number

K024286 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gyrus Endourology System: Axipolar Resectoscope Electrode

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  FDA 510(k) K994166 Active Cleared 27 Dec 1999

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  FDA 510(k) K031081 Active Cleared 21 May 2003

• Zip Open Forceps with Electrosurgical Cut

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  FDA 510(k) K020585 Active Cleared 13 Jul 2002

• Gyrus Plasma Skin Resurfacing System

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  FDA 510(k) K041999 Active Cleared 2 Mar 2005

• Plasmakinetic Endourology System

  Class II

  FDA 510(k) K003569 Active Cleared 19 Dec 2000

• Gyrus Plasmacision Laparoscopic Spatula

  Class II

  FDA 510(k) K041633 Active Cleared 22 Oct 2004

See all devices from Gyrus Medical, Ltd. →