New Standard Device recalls

New Standard Device has 4 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 21 Jun 2023. 3 are still ongoing.

Total recalls4since 2022

Last 12 months0reported

Class I00% of total

Ongoing3latest 21 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why new standard device is recalled

Other Reasons250%
Device Malfunction250%

Product types

Other Medical Devices375%
Hip & Knee Implants125%

By year

2023125%
2022375%

Ongoing new standard device recalls

3 active

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Device	CLASS II	'n'-Hole Post which is a component of the Revolution recalled	New Standard Device	Other	Nationwide
7 Sep 2022Device	CLASS II	Metalogix Self-Drill Half-Pin recalled by New Standard Device	New Standard Device	Device Malfunction	11 states
29 Jun 2022Device	CLASS II	Metalogix Slotted 90 Tubular Wrench recalled by New Standard Device	New Standard Device	Other	5 states

All new standard device recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Device	CLASS II	'n'-Hole Post which is a component of the Revolution recalled	New Standard Device	Other	Nationwide
7 Sep 2022Device	CLASS II	Metalogix Self-Drill Half-Pin recalled by New Standard Device	New Standard Device	Device Malfunction	11 states
29 Jun 2022Device	CLASS II	Metalogix Slotted 90 Tubular Wrench recalled by New Standard Device	New Standard Device	Other	5 states
15 Jun 2022Device	CLASS II	Truss Wire recalled by New Standard Device	New Standard Device	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.