Hyfrecator, #733

• 2 recalls, same reason

  • Terminated Z-0827-2013 FDA Class II ·initiated 28 Jan 2013
  • Terminated Z-0826-2013 FDA Class II ·initiated 28 Jan 2013

  Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

• 2 recalls, same reason

  • Terminated Z-0718-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0719-2013 FDA Class II ·initiated 27 Dec 2012

  ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.

510(k) Number

K800617 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Pencil Holder 720

  Class II

  FDA 510(k) K850297 Active Cleared 28 Feb 1985

• Cardiocassette II #363

  Class II

  FDA 510(k) K821453 Active Cleared 25 May 1982

• Shortwave Diathermy Model 802

  Class II

  FDA 510(k) K780755 Active Cleared 12 May 1978

• Birt-A-Chuck Disposable Electr. Handle

  Class II

  FDA 510(k) K760722 Active Cleared 1 Nov 1976

• Surgical Cauteries Models 775-11, 12, 13, 31, 32 & 33

  Class II

  FDA 510(k) K854814 Active Cleared 13 Jan 1986

• Model 375 ECG

  Class II

  FDA 510(k) K881328 Active Cleared 18 May 1988

See all devices from Birtcher Corp. →