EBI, LLC is recalling approximately 2,835 units of Biomet SpinalPak and OrthoPak Bone Growth Stimulator systems and replacement lead wires distributed since May 1, 2023. The black protective sheath on the lead wire cables can become damaged, exposing the internal wires. This defect can prevent the therapeutic electrical signal from reaching the electrodes, which may lead to a significant delay in necessary medical treatment for bone healing. Consumers should check if their device or replacement lead wire kit is part of the affected distribution period.
The damaged cable sheath exposes internal wiring, which can cause the device to fail to deliver the required therapeutic signal to the bone site. This failure results in a delay of treatment for patients with non-healing bone fractures or those recovering from spine fusion surgery.
Consult healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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