Recall Z-1616-2024— EBI, LLC
Class II · Ongoing
Class II FDA medical device recall by EBI, LLC, initiated 2024-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet 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. 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.
- Recalling firm
- EBI, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-22
- Firm location
- Parsippany, NJ, United States
Product description
Biomet 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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.