Spine Fusion Stimulator Recalled for Damaged Lead Wire Sheath
The Biomet SpinalPak Spine Fusion Stimulator System is recalled for potential lead wire sheath damage that may prevent delivery of the therapeutic treatment signal. Devices distributed nationwide since May 2023 are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a therapeutic medical device where component damage can prevent intended treatment signal delivery. Although no illnesses or injuries have been reported, the device poses a risk of harm through treatment delay and failure of intended function. FDA Class II classification indicates moderate regulatory concern for medical devices.
Plain-English summary
The FDA has issued a recall of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System (Part Number 1067716) manufactured by EBI, LLC. This device is intended for treatment of established bone nonunion resulting from trauma, excluding vertebrae and flat bones.
The recall is due to potential damage to the lead wire sheath (black cable) component. When damaged, the internal wires may become exposed, which can prevent the therapeutic treatment signal from being delivered to the electrodes. This can result in delayed or absent treatment.
The recall affects all devices with UDI-DI 00812301020218 distributed in the United States since May 1, 2023. No illnesses or injuries have been reported in connection with this recall.
Patients and healthcare providers using this device should contact their healthcare provider for guidance. Healthcare providers may need to evaluate device functionality and determine if replacement or repair is necessary.
The recalled product
- 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
- Manufacturer
- EBI, LLC
- Hazard
- lead-wire-damage
- wire-exposure
- treatment-signal-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00812301020218 All devices distributed since May 1
- 2023
Distribution
Distributed nationwide across the United States.
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