Vanguard Complete Knee System

510(k) K113550

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK113550	Date29 Feb 2012Cleared	StatusActive

7 recalls · 2 ongoing · FDA

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 on shared 510(k) K113550
The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)