Osteomed recalls

Osteomed has 15 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 19 Jul 2023. 3 are still ongoing. The most frequent reason is device malfunction.

Total recalls15since 2020

Last 12 months0reported

Class I00% of total

Ongoing3latest 19 Jul 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 15 100%Class III 0 0%

Why osteomed is recalled

Product types

Other Medical Devices15100%

By year

2023213%
202117%
20201280%

Ongoing osteomed recalls

3 active

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023Device	CLASS II	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx recalled	Osteomed	Sterility	Nationwide
19 Jul 2023Device	CLASS II	REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only recalled	Osteomed	Sterility	Nationwide
15 Dec 2021Device	CLASS II	OsteoPower Power Console: -OsteoMed OsteoPower Power Console recalled	Osteomed	Other	Nationwide

All osteomed recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023Device	CLASS II	REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx recalled	Osteomed	Sterility	Nationwide
19 Jul 2023Device	CLASS II	REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only recalled	Osteomed	Sterility	Nationwide
15 Dec 2021Device	CLASS II	OsteoPower Power Console: -OsteoMed OsteoPower Power Console recalled	Osteomed	Other	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 3cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 5cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation 3cc Impactformula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovationex 2cc Inject Formula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation RMX 10 CC Injectable recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation 10 Cc Impact Formula recalled by Osteomed	Osteomed	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Osteovation 5cc Inject Formula recalled by Osteomed	Osteomed	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.