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'vanguard(Tm) 32-489104

by Biomet Orthopedics, Inc.

'vanguard(Tm) 32-489104 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K113550 on 29 Feb 2012 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00880304444546), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K113550

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304444546 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113550 Date29 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113550 decided 29 Feb 2012 Active
  • FDA GUDID UDI-DI 00880304444546 listed 22 Sep 2016 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

9 dated events

  1. Cleared FDA 510(k) K113550
  2. Listed FDA GUDID 00880304444546
  3. Recall initiated FDA recalls Z-1011-2018
  4. Recall initiated FDA recalls Z-2183-2018
  5. Recall initiated FDA recalls Z-2289-2018
  6. Recall initiated FDA recalls Z-0495-2019
  7. Recall initiated FDA recalls Z-0496-2019
  8. Recall initiated FDA recalls Z-1042-2023
  9. Recall initiated FDA recalls Z-1043-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
'vanguard(Tm)
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
32-489104
Primary DI / UDI-DI
00880304444546
510(k) Number
FDA product code
MBH, OIY, JWH
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class II
Regulation number
888.3565, 888.3560
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 (K113550)

and 8 more cleared under K113550

Similar devices in this category

Other devices filed under Knee tibia prosthesis trial, reusable.

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, all answered No)