Vanguard Knee System 183643

• FDA 510(k) K171054 decided 28 Jul 2017 Active· +1 more in the status table
• FDA GUDID UDI-DI 00880304673939 listed 24 Oct 2015 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).

• • Terminated Z-0938-2019 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.

• 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-2177-2018 FDA Class II ·initiated 18 May 2018

  One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

• • 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. 28 Jul 2017 Cleared FDA 510(k) K171054
2. 3 Oct 2017 Recall initiated FDA recalls Z-1011-2018
3. 11 May 2018 Recall initiated FDA recalls Z-2183-2018
4. 18 May 2018 Recall initiated FDA recalls Z-2177-2018
5. 24 May 2018 Recall initiated FDA recalls Z-2289-2018
6. 22 Oct 2018 Recall initiated FDA recalls Z-0495-2019
7. 22 Oct 2018 Recall initiated FDA recalls Z-0496-2019
8. 21 Dec 2018 Recall initiated FDA recalls Z-0938-2019
9. 29 Dec 2022 Recall initiated FDA recalls Z-1042-2023
10. 29 Dec 2022 Recall initiated FDA recalls Z-1043-2023

2 earlier events are in the sections above.

Trade name

Vanguard Knee System

Generic name

Tibial insert

Model / Ref / Catalog

183643

Primary DI / UDI-DI

00880304673939

510(k) Number

K113550 ↗

K171054 ↗

FDA product code

JWH, MBH, OIY, HRY, MBV

GMDN term

Tibial insert

Device class

Class II

Regulation number

888.3560, 888.3565, 888.3530

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Tibial insert

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