EBI, LLC

FDA recalling firm · 10 enforcement events · 13 product records · 2012–2024 · NJ

EBI, LLC has 10 FDA enforcement events on this register (13 product records) between 2012 and 2024: 10 device; the busiest year was 2013 with 5.

0% of its events are Class I; the most common class is Class II (10). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
22 Mar 2024	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716	Device	Class II	4	Ongoing
11 Nov 2014	Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.	Device	Class II	1	Terminated
8 Oct 2014	Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.	Device	Class II	1	Terminated
15 May 2014	Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.	Device	Class II	1	Terminated
24 Sep 2013	Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and…	Device	Class II	1	Terminated
22 Aug 2013	BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system	Device	Class II	1	Terminated
13 Aug 2013	Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662	Device	Class II	1	Terminated
9 Apr 2013	Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.	Device	Class II	1	Terminated
7 Feb 2013	Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.	Device	Class II	1	Terminated
29 Sep 2012	Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178	Device	Class II	1	Terminated

By type and class

Device10

Class II10

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for EBI, LLC by year initiated.

Questions and answers

How many FDA recalls has EBI, LLC had?

10 enforcement events (13 product records) on this register, 2012–2024: 10 device.

Are any EBI, LLC recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are EBI, LLC recalls?

10 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.