EBI, LLC
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for EBI, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-05-01FDA-DeviceClass II48" Lead Wires, Replacement Part Number: 1067724-4
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
- 2024-05-01FDA-DeviceClass II20" Lead Wires, Replacement Part Number: 1067724-2
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
- 2024-05-01FDA-DeviceClass IIBiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
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
- 2024-05-01FDA-DeviceClass IIBiomet 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
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