Vanguard® 32-489083

• EUDAMED Basic UDI-DI 889024BDV2F registered 30 Oct 2026 Active
• FDA 510(k) K113550 decided 29 Feb 2012 Active
• FDA GUDID UDI-DI 00887868497926 listed 24 Mar 2021 Listed

• 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.

1. 29 Feb 2012 Cleared FDA 510(k) K113550
2. 3 Oct 2017 Recall initiated FDA recalls Z-1011-2018
3. 11 May 2018 Recall initiated FDA recalls Z-2183-2018
4. 24 May 2018 Recall initiated FDA recalls Z-2289-2018
5. 22 Oct 2018 Recall initiated FDA recalls Z-0495-2019
6. 22 Oct 2018 Recall initiated FDA recalls Z-0496-2019
7. 24 Mar 2021 Listed FDA GUDID 00887868497926
8. 29 Dec 2022 Recall initiated FDA recalls Z-1042-2023
9. 29 Dec 2022 Recall initiated FDA recalls Z-1043-2023
10. 30 Oct 2026 Registered EUDAMED 889024BDV2F

Trade name

Vanguard®

Generic name

Knee tibia prosthesis trial, reusable

Device name

Vanguard AS Bearing Trial

Model / Ref / Catalog

32-489083

Primary DI / UDI-DI

00887868497926

Basic UDI-DI

889024BDV2F

Direct marketing DI

00887868497926

510(k) Number

K113550 ↗

FDA product code

JWH, OIY, MBH

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

888.3560, 888.3565

EU registration type

Standard device

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Knee tibia prosthesis trial, reusable

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