Acufex Endobutton Tape

• • Terminated Z-1536-2018 FDA Class II ·initiated 11 Dec 2017 ·on shared 510(k) K952535

  Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

• • Terminated Z-2745-2016 FDA Class II ·initiated 19 Jul 2016 ·on shared 510(k) K952535

  Sterility compromised due to breach in sterile packaging

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

510(k) Number

K952535 ↗

FDA Product Code

GAT

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SN

• Acufex Metal Acl Cannula

  Class II

  FDA 510(k) K932718 Active Cleared 21 Mar 1994

• Acufex Endofix Absorbable Interference Screw

  Class II

  FDA 510(k) K954246 Active Cleared 15 Feb 1996

• Acufex Arthroscopic Shoulder Guide System

  Class II

  FDA 510(k) K940481 Active Cleared 6 May 1994

• Acufex Arthroscopic Shaver

  Class I

  FDA 510(k) K844130 Active Cleared 21 Mar 1985

• Acufex Endobutton System

  Class II

  FDA 510(k) K933948 Active Cleared 21 Jul 1994

• Flouroshield Radiation Reduction Glove

  Class I

  FDA 510(k) K893093 Active Cleared 13 Feb 1990

See all devices from Acufex Microsurgical, Inc. →