Data / Medical devices / United States / Ebi, LLC
Ebi, LLC: FDA-registered device maker in Parsippany, NJ, United States, 4 PMA approvals
Ebi, LLC is registered with the FDA (registration 2242816) in Parsippany, NJ, United States. It lists 2 device types. The FDA files 4 PMA approvals under its listings, the newest dated April 30, 1987. 19 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2242816
- Address
- 1 Gatehall Rd. Suite 303, Parsippany, NJ, United States, 07054
- Owner or operator
- EBI, LLC - AHP EOS Buyer Inc. (2242816)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 27, 2008
- Registered through
- 2026
- Brand names listed
- Biomet BHS Mini, Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System, Biomet Spinalpak Non-invasive Spine Fusion Stimulator System, EBI Bone Healing System, EBI Bone Healing System-Model 2100, EBI Osteogen Implantable Growth Sti, EBI SPF Implantable Spinal Fusion S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Invasive Bone Growth | LOE | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 1987 | P850035 | SpF® Implantable Spinal Fusion Stimulator | LOE | 51 | September 20, 2024 | accessdata.fda.gov |
| February 18, 1986 | P850022 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy | LOF | 31 | February 29, 2024 | accessdata.fda.gov |
| January 25, 1980 | P790005 | OsteoGenTM Implantable Bone Growth Stimulators | LOE | 58 | November 23, 2022 | accessdata.fda.gov |
| November 6, 1979 | P790002 | Biomet(R) EBI BONE Healing System | LOF | 35 | October 26, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 22, 2024 | 94291 | Class II | Ongoing | 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 | 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 | accessdata.fda.gov |
| November 11, 2014 | 69981 | Class II | Terminated | 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 u | 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. | accessdata.fda.gov |
| October 8, 2014 | 69785 | Class II | Terminated | 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 sp | 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. | accessdata.fda.gov |
| May 15, 2014 | 68526 | Class II | Terminated | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. | The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. | accessdata.fda.gov |
| September 24, 2013 | 66654 | Class II | Terminated | 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 stab | Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. | accessdata.fda.gov |
| August 22, 2013 | 66300 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| August 13, 2013 | 66098 | Class II | Terminated | 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 14-501 | Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. | accessdata.fda.gov |
| April 9, 2013 | 65043 | Class II | Terminated | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. | Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. | accessdata.fda.gov |
| February 7, 2013 | 64452 | Class II | Terminated | 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. | Increased risk of failure at the driver tip during screw insertion or removal. | accessdata.fda.gov |
| September 29, 2012 | 63653 | Class II | Terminated | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 | Broken screw insertor hardness was measured and found to be below the acceptable limits. | accessdata.fda.gov |
| September 16, 2010 | 56791 | Not yet classified | Terminated | ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054 | 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. | accessdata.fda.gov |
| April 2, 2009 | 51730 | Not yet classified | Terminated | TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in the alignment and st | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. | accessdata.fda.gov |
| March 27, 2009 | 51725 | Not yet classified | Terminated | Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 Intended to aid in the alignment and stabilization of fractures t | Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices. | accessdata.fda.gov |
| May 7, 2008 | 48158 | Not yet classified | Terminated | Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail | Customer complaint received regarding the separation of the mallet handle during a medical procedure. | accessdata.fda.gov |
| October 23, 2007 | 45502 | Not yet classified | Terminated | OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteob | Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive) | accessdata.fda.gov |
| September 6, 2006 | 36377 | Not yet classified | Terminated | VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only | VHS Plate and lag screw components did not assemble correctly intraoperatively. | accessdata.fda.gov |
| June 24, 2005 | 32813 | Not yet classified | Terminated | EBI Trochanteric 11mm Long Nail. | Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification. | accessdata.fda.gov |
| March 16, 2005 | 31822 | Not yet classified | Terminated | EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle Arthrodesis Nail Instr., Part Number 469055. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. | accessdata.fda.gov |
| June 17, 2003 | 26512 | Not yet classified | Terminated | EBI VueCath Endoscopic Spinal System | Non sterile device is labeled sterile. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.