Genesis Unicompartmental Knee System

• 2 recalls, same reason

  • Terminated Z-0305-05 FDA Unclassified (pre-2012) ·initiated 21 Jun 2004 ·on shared 510(k) K912735
  • Terminated Z-0304-05 FDA Unclassified (pre-2012) ·initiated 21 Jun 2004

  The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

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

510(k) Number

K912735 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SN

• Hydrocell Nasal and Sinus Packs

  Class I

  FDA 510(k) K954491 Active Cleared 15 Nov 1995

• Black Oval-Top Torp/Porp

  Class II

  FDA 510(k) K934107 Active Cleared 8 Jun 1994

• Profix Conforming Plus Tibial Insert

  Class II

  FDA 510(k) K946236 Active Cleared 6 Jul 1995

• Epistaxis Nasal Balloon Catheter

  Class I

  FDA 510(k) K921199 Active Cleared 8 Jul 1992

• Geri Total Hip System

  Class II

  FDA 510(k) K905186 Active Cleared 15 Feb 1991

• Rihards Titanium Half Pin

  Class II

  FDA 510(k) K920024 Active Cleared 21 Jan 1992

See all devices from Smith & Nephew Richards, Inc. →