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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Implant Remover	IRFS	FDA UDI	Class I	Active
BLT II Implant	BLOS5507C2	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068315	FDA UDI	Class III	Active
BLT II Implant	BLOS5509C2	FDA UDI	Class II	Unknown
SpF®-PLUS-Mini (60 uA/M)	10-1398M	FDA UDI	Class III	Active
BestDuo Abutment	NOA615	FDA UDI	Class II	Active
SpF®-PLUS-Mini (60 uA/W)	10-1398W	FDA UDI	Class III	Active
Reficio DBM Plus	20900421	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068210	FDA UDI	Class III	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067716-45	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068226	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068237	FDA UDI	Class III	Active
Precision II Implant	IRSS4110	FDA UDI	Class II	Active
Lindemann Guide Drill	LD	FDA UDI	Class I	Active
BLT II Implant	BLOS4109T	FDA UDI	Class II	Active
Precision II Implant	IRSS3311	FDA UDI	Class II	Active
Precision II Implant	IRSS4106	FDA UDI	Class II	Active
CCM UCLA Abutment (for BESTic) [OCT]	EBCUC	FDA UDI	Class II	Unknown
Biomet SpinalPak / OrthoPak	1067728	FDA UDI	Class III	Active
BESTic Healing Abutment	BHAR524	FDA UDI	Class II	Active
EBI OsteoGen™ Implantable Bone Growth Stimulator	10-1322M	FDA UDI	Class III	Active
Implant Analog	OSR	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068208	FDA UDI	Class III	Active
External Implant (3i type)	EE3R4008H	FDA UDI	Class II	Active
Biomet OrthoPak Non-invasive Bone Growth Stimulator System	1067718-72	FDA UDI	Class III	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067716-63	FDA UDI	Class II	Active
Lindemann Guide Drill	OMD2228	FDA UDI	Class I	Active
Biomet EBI Bone Healing System	1068239	FDA UDI	Class II	Active
BLT External Implant(SLA)	BLERS4110	FDA UDI	Class II	Active
Sinus Kit	SCC	FDA UDI	Class I	Active
Precision II Implant	IRSS4812	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068339	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068233	FDA UDI	Class III	Active
BestDuo Abutment Screw	NOAS	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068227	FDA UDI	Class III	Active
Precision II Implant	IWSS4809	FDA UDI	Class II	Active
Implant Analog	SLAS	FDA UDI	Class II	Active
Biomet SpinalPak / OrthoPak	106130-22	FDA UDI	Class III	Active
Biomet EBI Bone Healing System	1068228	FDA UDI	Class II	Active
Biomet SpinalPak / OrthoPak	106130-20	FDA UDI	Class III	Active
Biomet SpinalPak / OrthoPak	1067729	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068314	FDA UDI	Class III	Active
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	1067717	FDA UDI	Class III	Active
Precision II Implant	IRSS4109	FDA UDI	Class II	Active
External Implant (3I type)	EE3M3308H	FDA UDI	Class II	Active
Stop Drill Kit	EPK	FDA UDI	Class I	Active
BLT II Implant	BLOS4112	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068313	FDA UDI	Class III	Active
BESTic Healing Abutment	BHAR432	FDA UDI	Class II	Active
Biomet OrthoPak Non-invasive Bone Growth Stimulator System	1067718-45	FDA UDI	Class III	Active

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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.