Ebi recalls

Ebi appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2024-05-01.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to…
  FDA Device · Class II · 2024-05-01 · Ebi
  Reason: 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
• Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to tra…
  FDA Device · Class II · 2024-05-01 · Ebi
  Reason: 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
• 20" Lead Wires, Replacement Part Number: 1067724-2
  FDA Device · Class II · 2024-05-01 · Ebi
  Reason: 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
• 48" Lead Wires, Replacement Part Number: 1067724-4
  FDA Device · Class II · 2024-05-01 · Ebi
  Reason: 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
• Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws
  FDA Device · Class II · 2015-01-14 · Ebi
  Reason: 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.
• Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical…
  FDA Device · Class II · 2014-12-31 · Ebi
  Reason: 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…
• Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System
  FDA Device · Class II · 2014-06-25 · Ebi
  Reason: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
• Shortened Plug Driver
  FDA Device · Class II · 2013-12-04 · Ebi
  Reason: Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
• BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System
  FDA Device · Class II · 2013-11-27 · Ebi
  Reason: 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.
• Solitaire-35 Peek Solitaire Anterior Spinal System
  FDA Device · Class II · 2013-10-09 · Ebi
  Reason: Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
• Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054
  FDA Device · Class II · 2013-09-25 · Ebi
  Reason: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
• Biomet Spine Polaris 5.5 Button Lock Screw Inserter
  FDA Device · Class II · 2013-03-27 · Ebi
  Reason: Increased risk of failure at the driver tip during screw insertion or removal.
• Biomet Polaris 5.5 Button Lock Screw Inserter
  FDA Device · Class II · 2012-12-26 · Ebi
  Reason: Broken screw insertor hardness was measured and found to be below the acceptable limits.