Is this your brand? Sign in to claim ownership.

Ebi, LLC

Last updated September 17, 2026

Information

Country: US
Address: 1 Gatehall Rd., PARSIPPANY, NJ, 07054
Website: biomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1.973.299.9300
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2242816
DUNS Number: 050410323

Catalogue (168)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1320	FDA UDI	Class III	Active
EBI OsteoGen Implantable Bone Growth Stimulator	10-1318	FDA UDI	Class III	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1322S	FDA UDI	Class III	Active
Biomet SpinalPak / OrthoPak	1067759	FDA UDI	Class III	Active
BestDuo Abutment	BTAN417	FDA UDI	Class II	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1320M	FDA UDI	Class III	Active
Precision II Implant	IRSS4113	FDA UDI	Class II	Active
BLT II Implant	BLOS4112T	FDA UDI	Class II	Active
BESTic Healing Abutment	BHAR522	FDA UDI	Class II	Active
Biomet SpinalPak / OrthoPak	106130-12	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068223	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068234	FDA UDI	Class II	Active
Biomet OrthoPak Non-invasive Stimulator	1067783-1	FDA UDI	Class III	Active
Biomet Bone Healing System	1068317	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068240	FDA UDI	Class III	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1328M	FDA UDI	Class III	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067716	FDA UDI	Class III	Active
Biomet OrthoPak Non-invasive Bone Growth Stimulator System	1067718	FDA UDI	Class II	Active
BLT OS Abutment Screw	ONOASR	FDA UDI	Class II	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067716-72	FDA UDI	Class II	Active
BESTic Healing Abutment	BHAR424	FDA UDI	Class II	Active
Precision II Implant	IWSS4811	FDA UDI	Class II	Active
Precision II Implant	IRSS4810	FDA UDI	Class II	Active
BLT II Implant	BLOS4111T	FDA UDI	Class II	Active
Implant Analog Wide	SWAS	FDA UDI	Class II	Active
External Implant (3i type)	EE3R4010H	FDA UDI	Class II	Active
Precision II Implant	IRSS4811	FDA UDI	Class II	Active
Precision II Implant	IRSS4812	FDA UDI	Class II	Active
Reficio DBM Paste	20700421	FDA UDI	Class II	Active
BESTic Healing Abutment	BHAR523	FDA UDI	Class II	Active
BLT External Implant(SLA)	BLERS4107	FDA UDI	Class II	Active
Precision II Implant	IRSS4814	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068222	FDA UDI	Class III	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067725	FDA UDI	Class III	Active
BestDuo Abutment	TAN437	FDA UDI	Class II	Active
Stop Drill Kit	SDK	FDA UDI	Class I	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067783-2	FDA UDI	Class III	Active
BLT Octa Analog	BLOLA	FDA UDI	Class II	Active
External Implant (3i type)	EE3W5008H	FDA UDI	Class II	Active
BestDuo Abutment	TAN417	FDA UDI	Class II	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1348S	FDA UDI	Class III	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1348M	FDA UDI	Class III	Active
Precision II Implant	IWSS4810	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068229	FDA UDI	Class III	Active
Precision II Implant	IRSS4813	FDA UDI	Class II	Active
CCM UCLA Abutment (for Precision) [OCT]	EICUC	FDA UDI	Class II	Unknown
Implant Remover	IRFL	FDA UDI	Class I	Active
Biomet OrthoPak Non-invasive Bone Growth Stimulator System	1067719	FDA UDI	Class III	Active
BESTic Healing Abutment	BHAR534	FDA UDI	Class II	Active
BLT II Implant	BLOS4108	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 22, 2024	Z-1619-2024	—	open, classified	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Mar 22, 2024	Z-1617-2024	—	open, classified	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Mar 22, 2024	Z-1616-2024	—	open, classified	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Mar 22, 2024	Z-1618-2024	—	open, classified	Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Nov 11, 2014	Z-0874-2015	—	terminated	A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Oct 8, 2014	Z-0909-2015	—	terminated	Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
May 15, 2014	Z-1811-2014	—	terminated	The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Sep 24, 2013	Z-0411-2014	—	terminated	Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Aug 22, 2013	Z-0359-2014	—	terminated	Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
Aug 13, 2013	Z-2214-2013	—	terminated	Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Apr 9, 2013	Z-2292-2013	—	terminated	Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Feb 7, 2013	Z-0954-2013	—	terminated	Increased risk of failure at the driver tip during screw insertion or removal.
Sep 29, 2012	Z-0536-2013	—	terminated	Broken screw insertor hardness was measured and found to be below the acceptable limits.
Sep 16, 2010	Z-0131-2011	—	terminated	One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.