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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 4 of 4

Device	Model / Reference	Registries	Class	Status
Reficio DBM Plus	20900521	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068238	FDA UDI	Class II	Active
Biomet EBI Bone Healing System	1068235	FDA UDI	Class II	Active
BLT OS Analog	OBLHLAR	FDA UDI	Class I	Active
Biomet SpinalPak / OrthoPak	1067724-4	FDA UDI	Class II	Active
Reficio DBM Plus	20800521	FDA UDI	Class II	Active
Stop Drill Kit	DHK	FDA UDI	Class I	Active
BLT II Implant	BLOS4110	FDA UDI	Class II	Active
BLT II Implant	BLOS4113	FDA UDI	Class II	Active
BLT II Implant	BLOS4810	FDA UDI	Class II	Active
BLT OS Impression Coping	ONOICTR	FDA UDI	Class I	Active
Solitaire-C Cervical Spacer System	K113796	FDA 510(k)	Class II	Active
Ebi Internal Implant System	K073116	FDA 510(k)	Class II	Active
Polaris Spinal System -translation Screw	K140123	FDA 510(k)	Class II	Active
Internal Octa Implant System	K170031	FDA 510(k)	Class II	Active
Nextgen Altius Oct System	K140734	FDA 510(k)	Class II	Active
EBI External Implant System	K142426	FDA 510(k)	Class II	Active
Construx External Fixation Device	K111376	FDA 510(k)	Class II	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.