Surgical Cutter

• • Terminated Z-2767-2015 FDA Class II ·initiated 29 Jul 2015 ·on shared 510(k) K955168

  Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.

• • Terminated Z-2045-2016 FDA Class II ·initiated 24 Feb 2014 ·on shared 510(k) K955168

  This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K955168 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Automated Vitrectomy Device

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• Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle

  Class II

  FDA 510(k) K945146 Active Cleared 21 Dec 1994

• Breast Lesion Localization Needle

  Class I

  FDA 510(k) K945124 Active Cleared 22 Nov 1994

• Augastroenterology-Urology Biopsy Instrument

  Class II

  FDA 510(k) K954231 Active Cleared 22 Sep 1995

• Co-Axial Introducer Needle

  Class II

  FDA 510(k) K022634 Active Cleared 6 Nov 2002

• Automated Core Biopsy Device

  Class II

  FDA 510(k) K994272 Active Cleared 7 Jan 2000

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