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Alumina Ceramic Femoral Heads, 28 and 32 Mm

by Zimmer, Inc.

510(k) K030724

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030724 Date3 Jun 2003ClearedStatusActive

Recalls

7 recalls · FDA

    • Terminated Z-1616-2009 FDA Unclassified (pre-2012) initiated 29 May 2009

    The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

  • 6 recalls, same reason

    • Terminated Z-0299-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008
    • Terminated Z-0300-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008
    • Terminated Z-0302-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008
    • Terminated Z-0301-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008
    • Terminated Z-0304-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008
    • Terminated Z-0303-2009 FDA Unclassified (pre-2012) initiated 11 Jun 2008

    When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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