Vanguard Knee System 184728

• FDA 510(k) K171054 decided 28 Jul 2017 Active· +1 more in the status table
• FDA GUDID UDI-DI 00880304436688 listed 24 Oct 2015 Listed

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

  Potential presence of elevated endotoxin levels that exceed the specification limit

• 2 recalls, same reason

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

• • 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-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-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
  • 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

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

1. 4 Oct 2011 Recall initiated FDA recalls Z-0701-2012
2. 24 Oct 2015 Listed FDA GUDID 00880304436688
3. 17 Feb 2017 Recall initiated FDA recalls Z-1861-2017
4. 28 Jul 2017 Cleared FDA 510(k) K171054
5. 11 May 2018 Recall initiated FDA recalls Z-2183-2018
6. 18 May 2018 Recall initiated FDA recalls Z-2177-2018
7. 24 May 2018 Recall initiated FDA recalls Z-2289-2018
8. 21 Dec 2018 Recall initiated FDA recalls Z-0937-2019
9. 21 Dec 2018 Recall initiated FDA recalls Z-0938-2019
10. 17 Apr 2020 Recall initiated FDA recalls Z-2154-2020

10 earlier events are in the sections above.

Trade name

Vanguard Knee System

Generic name

Polyethylene patella prosthesis

Model / Ref / Catalog

184728

Primary DI / UDI-DI

00880304436688

510(k) Number

K040770 ↗

K171054 ↗

FDA product code

JWH, MBH, HRY, MBV, OIY

GMDN term

Polyethylene patella prosthesis

Device class

Class II

Regulation number

888.3560, 888.3565, 888.3530

GUDID distribution status

In Commercial Distribution

Category: Polyethylene patella prosthesis

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