fda
10 records
FDA Device Recall: 48" Lead Wires, Replacement Part Number: 1067724-4
2024-05-01
Class II — 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 i...
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FDA Device Recall: Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the
2024-05-01
Class II — 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 i...
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FDA Device Recall: Cypher MIS Screw System-The system includes screws, various types and sizes of r
2015-01-14
Class II — 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.
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FDA Recall: Ebi, Llc — Class II
20141231
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill | Product: Solitaire-C Cervical Spacer System ...
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FDA Device Recall: Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-53159
2014-12-31
Class II — 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 m...
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FDA Device Recall: Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument f
2014-06-25
Class II — The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
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FDA Recall: Ebi, Llc — Class II
20131127
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head f | Product: BIOMET Spine, 5.5 TI 5.5x50mm Transla...
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FDA Device Recall: Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile;
2013-12-04
Class II — Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
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FDA Device Recall: BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. R
2013-11-27
Class II — 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 Translatio...
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FDA Device Recall: Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178.
2013-03-27
Class II — Increased risk of failure at the driver tip during screw insertion or removal.
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ftc_enforcement
1 records
lobbying
1 records
nppes
1 records
ny_corps
3 records
NY Corp: EBI GROUP INC.
2024-08-09
DOMESTIC BUSINESS CORPORATION | County: New York | Jurisdiction: New York
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NY Corp: EBI ASSOCIATES CORP.
2024-02-20
DOMESTIC BUSINESS CORPORATION | County: Rockland | Jurisdiction: New York
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NY Corp: EBI HOLDINGS, LLC
2008-08-27
FOREIGN LIMITED LIABILITY COMPANY | County: Rockland | Jurisdiction:
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ny_medicaid
1 records
NY Medicaid: EBI LLC
MEDICAL EQUIPMENT SUPPLIERS & DEALER | FFS | PARSIPPANY, OUT OF STATE
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