Depuy Corail Amt Hip Prosthesis

• • Terminated Z-2521-2018 FDA Class II ·initiated 21 Jun 2018 ·on shared 510(k) K123991

  Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.

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

510(k) Number

K123991 ↗

FDA Product Code

KWY

Device Class

Class II

Regulation

21 CFR Part 888.3390

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Deput Delta Xtend Reverse Shoulder

  Class II

  FDA 510(k) K120174 Active Cleared 11 Jun 2012

• 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