EBI Recalls
13 recalls on record · December 26, 2012 to May 1, 2024 · Medical Devices
Recalls by year
12
13
14
15
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 1, 2024Medical DevicesFDA
EBI, LLC recalls 48" Lead Wires, Replacement Part Number: 1067724-4
Hazard: 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
May 1, 2024Medical DevicesFDA
EBI, LLC recalls 20" Lead Wires, Replacement Part Number: 1067724-2
Hazard: 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
May 1, 2024Medical DevicesFDA
EBI, LLC recalls Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui
Hazard: 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
May 1, 2024Medical DevicesFDA
EBI, LLC recalls Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac
Hazard: 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
January 14, 2015Medical DevicesFDA
Ebi, Llc recalls Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instrument
Hazard: 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.
December 31, 2014Medical DevicesFDA
Ebi, Llc recalls Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Inte
Hazard: 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.
June 25, 2014Medical DevicesFDA
Ebi, Llc recalls Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Hazard: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
December 4, 2013Medical DevicesFDA
Ebi, Llc recalls Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 T
Hazard: Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
November 27, 2013Medical DevicesFDA
Ebi, Llc recalls BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for im
Hazard: 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.
October 9, 2013Medical DevicesFDA
Ebi, Llc recalls Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Hazard: Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
September 25, 2013Medical DevicesFDA
Ebi, Llc recalls Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixatio
Hazard: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
March 27, 2013Medical DevicesFDA
Ebi, Llc recalls Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-ce
Hazard: Increased risk of failure at the driver tip during screw insertion or removal.
December 26, 2012Medical DevicesFDA
Ebi, Llc recalls Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Hazard: Broken screw insertor hardness was measured and found to be below the acceptable limits.