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Vanguard® Instruments 32-483911

by Biomet Orthopedics, Inc.

Ref 32-483911

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BFLZW Basic UDI-DI 00887868491511UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868491511 UDI-DI Date8 May 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vanguard® Instruments
Generic Name
Knee tibia prosthesis trial, reusable
Device Name
Vanguard PS Plus 5in1 Locking Bearing Trial Posts
Model / Ref / Catalog
32-483911
Primary DI / UDI-DI
00887868491511
Basic UDI-DI
889024BFLZW
Direct Marketing DI
00887868491511
510(k) Number
FDA Product Code
MBH, OIY, JWH
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K113550)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No