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
Reported: May 1, 2024 Initiated: March 22, 2024 #Z-1616-2024
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
Details
- Recalling Firm
- EBI, LLC
- Units Affected
- N/A
- Distribution
- US Nationwide distribution.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by EBI, LLC. Units affected: N/A.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1616-2024.
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