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00-4828-034-02

by Zimmer, Inc.

Ref 00-4828-034-02

00-4828-034-02 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00889024072374), cleared under FDA 510(k) K063303 on 22 Nov 2006 and listed in FDA GUDID since 13 Jul 2016 (UDI-DI 00889024072374), active as of 7 Nov 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063303

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024072374 Basic UDI-DI 00889024072374UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024072374 UDI-DI Date13 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK063303 Date22 Nov 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024072374 registered 2 Nov 2026 Active
  • FDA 510(k) K063303 decided 22 Nov 2006 Active
  • FDA GUDID UDI-DI 00889024072374 listed 13 Jul 2016 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0312-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K063303

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

    • Terminated Z-1674-2016 FDA Class II initiated 4 May 2016

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

    • Terminated Z-1103-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    • Terminated Z-1042-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K063303
  2. Recall initiated FDA recalls Z-1042-2014
  3. Recall initiated FDA recalls Z-1103-2016
  4. Recall initiated FDA recalls Z-1674-2016
  5. Listed FDA GUDID 00889024072374
  6. Recall initiated FDA recalls Z-0312-2020
  7. Registered EUDAMED B-00889024072374

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Orthopaedic bone screw (non-sliding)
Device name
Universal Locking
Model / Ref / Catalog
00-4828-034-02
Primary DI / UDI-DI
00889024072374
Basic UDI-DI
B-00889024072374
510(k) Number
FDA product code
HWC
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 34 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K063303)

and 8 more cleared under K063303

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)