Osteonics Ha Generation II Acetabular Component System

• • Terminated Z-1043-2015 FDA Class II ·initiated 15 Dec 2014

  Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

• 2 recalls, same reason

  • Terminated Z-0073-2008 FDA Unclassified (pre-2012) ·initiated 30 Aug 2007
  • Terminated Z-0072-2008 FDA Unclassified (pre-2012) ·initiated 30 Aug 2007

  Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

• • Terminated Z-1261-2007 FDA Unclassified (pre-2012) ·initiated 13 Mar 2006

  Dimensional anomaly

510(k) Number

K983382 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

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