Ebi, Llc
Medical device manufacturer in Parsippany, NJ.
8510(k) clearances
0PMA approvals
14recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190837 | Internal Hex Implant SystemDZE · Traditional | 01/22/2020SE |
| K170031 | Internal Octa Implant SystemDZE · Traditional | 08/31/2017SE |
| K142426 | EBI External Implant SystemDZE · Traditional | 03/27/2015SE |
| K140734 | Nextgen Altius Oct SystemKWP · Traditional | 12/15/2014SE |
| K140123 | Polaris Spinal System -Translation ScrewNKB · Traditional | 04/24/2014SE |
| K113796 | Solitaire-C Cervical Spacer SystemOVE · Traditional | 04/26/2012SE |
| K111376 | Construx External Fixation DeviceKTT · Traditional | 08/03/2011SE |
| K073116 | Ebi Internal Implant SystemDZE · Traditional | 02/28/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1619-2024 Class II | 48" Lead Wires, Replacement Part Number: 1067724-4Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead… | 03/22/2024Open, Classified |
| Z-1618-2024 Class II | 20" Lead Wires, Replacement Part Number: 1067724-2Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead… | 03/22/2024Open, Classified |
| Z-1617-2024 Class II | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment…Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead… | 03/22/2024Open, Classified |
| Z-1616-2024 Class II | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the…Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead… | 03/22/2024Open, Classified |
| Z-0874-2015 Class II | Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594…A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve… | 11/11/2014Terminated |
| Z-0909-2015 Class II | Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and…Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of… | 10/08/2014Terminated |
| Z-1811-2014 Class II | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal…The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. | 05/15/2014Terminated |
| Z-0411-2014 Class II | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet…Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a… | 09/24/2013Terminated |
| Z-0359-2014 Class II | BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only.…Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally… | 08/22/2013Terminated |
| Z-2214-2013 Class II | Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System…Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. | 08/13/2013Terminated |
| Z-2292-2013 Class II | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an…Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire… | 04/09/2013Terminated |
| Z-0954-2013 Class II | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The…Increased risk of failure at the driver tip during screw insertion or removal. | 02/07/2013Terminated |
| Z-0536-2013 Class II | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178Broken screw insertor hardness was measured and found to be below the acceptable limits. | 09/29/2012Terminated |
| Z-0131-2011 | ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine…One of the two connector ends of the medium cross connector may not be fully secured to the rod after… | 09/16/2010Terminated |