Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171054	Date28 Jul 2017Decided	StatusActive
United States	GUDID listing	Number00880304265325 UDI-DI	Date24 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK022586	Date15 Aug 2002Decided	StatusActive

Recalls

4 recalls · FDA

- 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.

1 jurisdiction

United States — FDA 510(k) Active

GUDID

Show all (12)

Show all (12)

Also classified as Tibial insert.