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Vanguard XP® Instrumentation 32-700065

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

12 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868498671 UDI-DI Date24 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-2530-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2503-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2515-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2537-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2533-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2528-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2532-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2535-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2536-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2531-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2529-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2534-2019 FDA Class II initiated 15 Aug 2019

    The locking bar not fully engaging

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Vanguard XP® Instrumentation
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
32-700065
Primary DI / UDI-DI
00887868498671
510(k) Number
FDA product code
MBV, JWH, OIY, MBH
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class II
Regulation number
888.3560, 888.3565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K122160)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: 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