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Citation Tmzf Ha Stem

by Howmedica Osteonics Corp.

510(k) K993768

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK993768 Date21 Jan 2000ClearedStatusActive

Recalls

12 recalls · FDA

    • Terminated Z-1317-2014 FDA Class II initiated 3 Feb 2014

    Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.

  • 9 recalls, same reason

    • Terminated Z-1380-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1376-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1381-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1375-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1374-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1382-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1377-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1379-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009
    • Terminated Z-1378-2009 FDA Unclassified (pre-2012) initiated 6 Jan 2009

    Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

  • 2 recalls, same reason

    • Terminated Z-0349-03 FDA Unclassified (pre-2012) initiated 12 Nov 2002
    • Terminated Z-0350-03 FDA Unclassified (pre-2012) initiated 12 Nov 2002

    Hip Stem Fractures in the neck area.

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  • Withdrawn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
MEH
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Citation Tmzf Ha Stem is an orthopedic device, classified under the product code MEH. It is a type of femoral stem used in orthopedic procedures.

The device is supplied by Howmedica Osteonics Corp and has received FDA 510K clearance, indicated by the k number K993768. The device is used in orthopedic settings and is subject to regulatory oversight, with a recorded recall event in the FDA database.

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