EBI recalls

EBI has 13 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 1 May 2024. 4 are still ongoing.

Total recalls13since 2012

Last 12 months0reported

Class I00% of total

Ongoing4latest 1 May 2024

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 13 100%Class III 0 0%

Why ebi is recalled

Product types

Spinal Implants1077%
Other Medical Devices323%

By year

2024431%
201518%
2014215%
2013538%
201218%

Ongoing ebi recalls

4 active

Reported	Class	Recall	Company	Reason	Where
1 May 2024Device	CLASS II	Biomet OrthoPak Non-invasive Bone Growth Stimulator recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	20" Lead Wires, Replacement recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	Biomet SpinalPak Non-invasive Spine Fusion Stimulator recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	48" Lead Wires, Replacement recalled by EBI	EBI	Lead & Heavy Metals	Nationwide

All ebi recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
1 May 2024Device	CLASS II	Biomet OrthoPak Non-invasive Bone Growth Stimulator recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	20" Lead Wires, Replacement recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	Biomet SpinalPak Non-invasive Spine Fusion Stimulator recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
1 May 2024Device	CLASS II	48" Lead Wires, Replacement recalled by EBI	EBI	Lead & Heavy Metals	Nationwide
14 Jan 2015Device	CLASS II	Cypher MIS Screw System-The system includes screws recalled by Ebi	Ebi	Other	9 states
31 Dec 2014Device	CLASS II	Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl recalled	Ebi	Other	Nationwide
25 Jun 2014Device	CLASS II	Biomet Spine, Cypher MIS Screw Inserter recalled by Ebi	Ebi	Device Malfunction	Nationwide
4 Dec 2013Device	CLASS II	Shortened Plug Driver recalled by Ebi	Ebi	Sterility	CA
27 Nov 2013Device	CLASS II	Biomet Spine, 5 TI 5x50mm Translation Screw Polaris 5 TI recalled by Ebi	Ebi	Sterility	Nationwide
9 Oct 2013Device	CLASS II	Solitaire-35 Peek Solitaire Anterior Spinal System recalled by Ebi	Ebi	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.