Deput Delta Xtend Reverse Shoulder

• 2 recalls, same reason

  • Terminated Z-0833-2018 FDA Class II ·initiated 31 Aug 2017 ·on shared 510(k) K120174
  • Terminated Z-0834-2018 FDA Class II ·initiated 31 Aug 2017 ·on shared 510(k) K120174

  The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

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

510(k) Number

K120174 ↗

FDA Product Code

PHX

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Depuy Cta Reverse Shoulder System

  Class II

  FDA 510(k) K122442 Active Cleared 6 Sep 2012

• DePuy Corail AMT Hip Prosthesis

  Class II

  FDA 510(k) K173960 Active Cleared 21 Sep 2018

• Depuy Corail Amt Hip Prosthesis

  Class II

  FDA 510(k) K123991 Active Cleared 16 Sep 2013