Promos Modular Shoulder System

• 4 recalls, same reason

  • Terminated Z-1239-2010 FDA Unclassified (pre-2012) ·initiated 14 Jan 2010 ·on shared 510(k) K063578
  • Terminated Z-1240-2010 FDA Unclassified (pre-2012) ·initiated 14 Jan 2010 ·on shared 510(k) K063578
  • Terminated Z-1241-2010 FDA Unclassified (pre-2012) ·initiated 14 Jan 2010 ·on shared 510(k) K063578
  • Terminated Z-1242-2010 FDA Unclassified (pre-2012) ·initiated 14 Jan 2010 ·on shared 510(k) K063578

  Firm received complaints of Inclination Set Screws fracturing.

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

510(k) Number

K063578 ↗

FDA Product Code

HSD

FDA applicant

Plus Orthopedics AG

Device Class

Class II

Regulation

21 CFR Part 888.3690

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

See all devices from Plus Orthopedics →