Ulnar Head Implant

• • Terminated Z-0098-2014 FDA Class II ·initiated 6 Sep 2013 ·via K010786, on the same 510(k)

  The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K010786 ↗

FDA Product Code

KXE

Device Class

Class II

Regulation

21 CFR Part 888.3810

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Avanta Orthopaedics Trapezial Implant

  Class II

  FDA 510(k) K964381 Active Cleared 22 Jan 1997

• K'fix

  Class II

  FDA 510(k) K010847 Active Cleared 19 Jun 2001

• External Fixation

  Class II

  FDA 510(k) K981716 Active Cleared 17 Jul 1998

• Avanta Orthopaedics Trapezium Implant

  Class II

  FDA 510(k) K965204 Active Cleared 3 Jun 1997

• Avanta Orthopaedics Tendon Spacer

  Class II

  FDA 510(k) K964359 Active Cleared 25 Mar 1997

• Finger Joint Prosthesis

  Class II

  FDA 510(k) K013629 Active Cleared 25 Jan 2002

See all devices from Avanta Orthopaedics, Inc. →