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Vanguard® 360 Instrument 32-360646

by Biomet Orthopedics, Inc.

Ref 32-360646

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

5 closed

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 Number889024BCZ2L Basic UDI-DI 00887868484056UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868484056 UDI-DI Date22 Jun 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

5 recalls · FDA

    • Terminated Z-0723-2021 FDA Class II initiated 1 Dec 2020

    Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

  • 2 recalls, same reason

    • Terminated Z-3249-2018 FDA Class II initiated 2 Aug 2018
    • Terminated Z-3250-2018 FDA Class II initiated 2 Aug 2018

    The implant only has one bolt in the sterile package but it should have had two.

    • Terminated Z-0003-2017 FDA Class II initiated 8 Aug 2016

    The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.

    • Terminated Z-2242-2014 FDA Class II initiated 1 Jul 2014

    The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

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® 360 Instrument
Generic Name
Knee femur prosthesis trial, reusable
Device Name
Vanguard 360 Straight Stem Extension Trials
Model / Ref / Catalog
32-360646
Primary DI / UDI-DI
00887868484056
Basic UDI-DI
889024BCZ2L
Direct Marketing DI
00887868484056
510(k) Number
FDA Product Code
JWH, MBV
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Knee femur prosthesis trial, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
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 femur prosthesis trial, reusable

Cleared under the same submission (K093293)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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