Orthosoft recalls

Orthosoft has 7 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 9 Mar 2022. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls7since 2017

Last 12 months0reported

Class I00% of total

Ongoing1latest 9 Mar 2022

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 6 86%Class III 1 14%

Why orthosoft is recalled

Product types

By year

2022114%
2017686%

Ongoing orthosoft recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022Device	CLASS II	NavitrackER Kit A: Knee recalled by Orthosoft	Orthosoft	Lead & Heavy Metals	Nationwide

All orthosoft recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022Device	CLASS II	NavitrackER Kit A: Knee recalled by Orthosoft	Orthosoft	Lead & Heavy Metals	Nationwide
14 Jun 2017Device	CLASS II	Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty recalled	Orthosoft	Device Malfunction	CA, FL
24 May 2017Device	CLASS III	Navitrack¿ System - OS Knee Universal recalled by Orthosoft	Orthosoft	Device Malfunction	20 states
24 May 2017Device	CLASS II	Navitrack System - OS Knee Universal, Stereotaxic instrument recalled	Orthosoft	Device Malfunction	16 states
17 May 2017Device	CLASS II	NDI P7 Position Sensor, Stereotaxic Instrument recalled by Orthosoft	Orthosoft	Device Malfunction	8 states
3 May 2017Device	CLASS II	Navitrack System - OS Knee Universal recalled by Orthosoft	Orthosoft	Device Malfunction	Nationwide
26 Apr 2017Device	CLASS II	SmartTools Knee System Orthopedic Stereotaxic Instrument recalled	Orthosoft	Other	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.