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00-2358-107-03

by Zimmer, Inc.

Ref 00-2358-107-03

00-2358-107-03 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 889024-ZB001052-EQ), cleared under FDA 510(k) K082078 on 3 Nov 2008 and listed in FDA GUDID since 17 Oct 2015 (UDI-DI 00889024057197), active as of 7 Nov 2026. 5 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

7 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082078

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/MDR EUDAMED Number889024-ZB001052-EQ Basic UDI-DI 00889024057197UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024057197 UDI-DI Date17 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082078 Date3 Nov 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB001052-EQ registered 2 Nov 2026 Active
  • FDA 510(k) K082078 decided 3 Nov 2008 Active
  • FDA GUDID UDI-DI 00889024057197 listed 17 Oct 2015 Listed

Recalls

7 recalls · FDA

    • Terminated Z-0317-2020 FDA Class II initiated 10 Oct 2019

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

  • 5 recalls, same reason

    • Terminated Z-0589-2014 FDA Class II initiated 5 Nov 2013 on shared 510(k) K082078
    • Terminated Z-0588-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0585-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0591-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0587-2014 FDA Class II initiated 5 Nov 2013 on shared 510(k) K082078

    Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

    • Terminated Z-2101-2013 FDA Class II initiated 30 Jul 2013

    Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.

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

Timeline

10 dated events

  1. Cleared FDA 510(k) K082078
  2. Recall initiated FDA recalls Z-2101-2013
  3. Recall initiated FDA recalls Z-0589-2014
  4. Recall initiated FDA recalls Z-0588-2014
  5. Recall initiated FDA recalls Z-0585-2014
  6. Recall initiated FDA recalls Z-0591-2014
  7. Recall initiated FDA recalls Z-0587-2014
  8. Listed FDA GUDID 00889024057197
  9. Recall initiated FDA recalls Z-0317-2020
  10. Registered EUDAMED 889024-ZB001052-EQ

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Zimmer® Periarticular Locking Plate System
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
ZPLP Plate Humoral Distal Medial Right Short
Model / Ref / Catalog
00-2358-107-03
Primary DI / UDI-DI
00889024057197
Basic UDI-DI
889024-ZB001052-EQ
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 74 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 fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K082078)

and 8 more cleared under K082078

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)