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Novation Ceramic Articulation Hip System

by Exactech, Inc.

PMA P050039

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 5 Jul 2007

PMA

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP050039 Date5 Jul 2007Approval withdrawnStatusWithdrawn

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1901-2016 FDA Class II initiated 12 Apr 2016
    • Terminated Z-1905-2016 FDA Class II initiated 12 Apr 2016
    • Terminated Z-1903-2016 FDA Class II initiated 12 Apr 2016
    • Terminated Z-1900-2016 FDA Class II initiated 12 Apr 2016
    • Terminated Z-1904-2016 FDA Class II initiated 12 Apr 2016
    • Terminated Z-1902-2016 FDA Class II initiated 12 Apr 2016

    Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Novation Ceramic Ahs
Trade Name
Novation Ceramic Articulation Hip System
Generic Name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
PMA Number
FDA Product Code
MRA
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APWD Approval withdrawn

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