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Vanguard Instruments 32-480151

by Biomet Orthopedics, Inc.

Vanguard Instruments 32-480151 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K040770 on 22 Apr 2004 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00880304610460), active as of 23 Oct 2026. 13 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

None ongoing

13 closed

Documents

510(k) K040770

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 Number00880304610460 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK040770 Date22 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040770 decided 22 Apr 2004 Active
  • FDA GUDID UDI-DI 00880304610460 listed 28 Jul 2017 Listed

Recalls

13 recalls · FDA

    • Terminated Z-2154-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-0937-2019 FDA Class II initiated 21 Dec 2018

    Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

    • Terminated Z-1861-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

  • 10 recalls, same reason

    • Terminated Z-0700-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0698-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0704-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0701-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0699-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0696-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0702-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0703-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0695-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011
    • Terminated Z-0697-2012 FDA Unclassified (pre-2012) initiated 4 Oct 2011

    Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-0699-2012
  2. Recall initiated FDA recalls Z-0696-2012
  3. Recall initiated FDA recalls Z-0702-2012
  4. Recall initiated FDA recalls Z-0703-2012
  5. Recall initiated FDA recalls Z-0695-2012
  6. Recall initiated FDA recalls Z-0697-2012
  7. Recall initiated FDA recalls Z-1861-2017
  8. Listed FDA GUDID 00880304610460
  9. Recall initiated FDA recalls Z-0937-2019
  10. Recall initiated FDA recalls Z-2154-2020

5 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vanguard Instruments
Generic name
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
32-480151
Primary DI / UDI-DI
00880304610460
510(k) Number
FDA product code
JWH
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Cleared under the same submission (K040770)

and 8 more cleared under K040770

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)