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Titan Tibial Nail

by Howmedica Osteonics Corp.

510(k) K003018

Titan Tibial Nail is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K003018 on 15 Dec 2000, active as of 22 Oct 2026. 21 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

22 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003018 Date15 Dec 2000ClearedStatusActive

Official records

Recalls

22 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2383-2020 FDA Class II initiated 7 May 2020
    • Terminated Z-2380-2020 FDA Class II initiated 7 May 2020
    • Terminated Z-2375-2020 FDA Class II initiated 7 May 2020
    • Terminated Z-2374-2020 FDA Class II initiated 7 May 2020

    Seal integrity of the blister pack may be compromised and sterility cannot be assured

  • 16 recalls, same reason

    • Terminated Z-2395-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2405-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2402-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2393-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2400-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2404-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2397-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2401-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2396-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2403-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2406-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2394-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2407-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2399-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2398-2018 FDA Class II initiated 27 Apr 2018
    • Terminated Z-2408-2018 FDA Class II initiated 27 Apr 2018

    The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

    • Terminated Z-0214-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K003018

    Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

    • Terminated Z-1295-03 FDA Unclassified (pre-2012) initiated 4 Aug 2003

    The device does not have an oblong hole for dynamic locking as required.

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

Timeline

23 dated events

  1. Recall initiated FDA recalls Z-2406-2018
  2. Recall initiated FDA recalls Z-2394-2018
  3. Recall initiated FDA recalls Z-2407-2018
  4. Recall initiated FDA recalls Z-2399-2018
  5. Recall initiated FDA recalls Z-2398-2018
  6. Recall initiated FDA recalls Z-2408-2018
  7. Recall initiated FDA recalls Z-2383-2020
  8. Recall initiated FDA recalls Z-2380-2020
  9. Recall initiated FDA recalls Z-2375-2020
  10. Recall initiated FDA recalls Z-2374-2020

13 earlier events are in the sections above.

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
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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