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02.03149.028

by Zimmer, Inc.

02.03149.028 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K043270 on 31 Jan 2005 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00889024295384), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K043270

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024295384 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043270 Date31 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043270 decided 31 Jan 2005 Active
  • FDA GUDID UDI-DI 00889024295384 listed 29 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0247-2013 FDA Class II initiated 4 Sep 2012

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

    • Terminated Z-1261-2009 FDA Unclassified (pre-2012) initiated 23 Mar 2009

    The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

Timeline

4 dated events

  1. Cleared FDA 510(k) K043270
  2. Recall initiated FDA recalls Z-1261-2009
  3. Recall initiated FDA recalls Z-0247-2013
  4. Listed FDA GUDID 00889024295384

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Femur intramedullary nail
Model / reference
02.03149.028
Primary DI / UDI-DI
00889024295384
510(k) Number
FDA product code
HWC, HSB
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3040, 888.3020
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.9 Millimeter
Length — 28 Millimeter

Related devices

Category: Femur intramedullary nail

Cleared under the same submission (K043270)

and 8 more cleared under K043270

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)