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Vanguard® 32-489068

by Biomet Orthopedics, Inc.

Part of a family of 64 devices: see the family page

Ref 32-489068

Vanguard® 32-489068 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024BDV2F), cleared under FDA 510(k) K113550 on 29 Feb 2012 and listed in FDA GUDID since 25 May 2022 (UDI-DI 00887868497858), active as of 7 Nov 2026. 7 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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113550

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 Number889024BDV2F Basic UDI-DI 00887868497858UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868497858 UDI-DI Date25 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113550 Date29 Feb 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024BDV2F registered 30 Oct 2026 Active
  • FDA 510(k) K113550 decided 29 Feb 2012 Active
  • FDA GUDID UDI-DI 00887868497858 listed 25 May 2022 Listed

Recalls

7 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1042-2023 FDA Class II initiated 29 Dec 2022
    • Ongoing Z-1043-2023 FDA Class II initiated 29 Dec 2022

    Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

  • 2 recalls, same reason

    • Terminated Z-0495-2019 FDA Class II initiated 22 Oct 2018
    • Terminated Z-0496-2019 FDA Class II initiated 22 Oct 2018

    Label on the outer carton or the patient labels does not match label on the inner sterile packaging

    • Terminated Z-2289-2018 FDA Class II initiated 24 May 2018

    Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

    • Terminated Z-2183-2018 FDA Class II initiated 11 May 2018

    The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

    • Terminated Z-1011-2018 FDA Class II initiated 3 Oct 2017

    The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Timeline

10 dated events

  1. Cleared FDA 510(k) K113550
  2. Recall initiated FDA recalls Z-1011-2018
  3. Recall initiated FDA recalls Z-2183-2018
  4. Recall initiated FDA recalls Z-2289-2018
  5. Recall initiated FDA recalls Z-0495-2019
  6. Recall initiated FDA recalls Z-0496-2019
  7. Listed FDA GUDID 00887868497858
  8. Recall initiated FDA recalls Z-1042-2023
  9. Recall initiated FDA recalls Z-1043-2023
  10. Registered EUDAMED 889024BDV2F

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
Vanguard®
Generic name
Knee tibia prosthesis trial, reusable
Device name
Vanguard AS Bearing Trial
Model / Ref / Catalog
32-489068
Primary DI / UDI-DI
00887868497858
Basic UDI-DI
889024BDV2F
Direct marketing DI
00887868497858
510(k) Number
FDA product code
MBH, JWH, OIY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3565, 888.3560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K113550)

and 8 more cleared under K113550

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)