Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage
The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.
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 Class II recall involves a medical device where potential lead wire sheath damage could prevent therapeutic signal delivery, representing a risk-of-harm to patients. No illnesses, injuries, or treatment delays have been reported. Per the rubric, this qualifies as Score 3 (High) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is being recalled due to potential damage to the lead wire sheath (black cable component) that could expose internal wires. This damage may prevent the device from delivering therapeutic signals to treatment electrodes, potentially delaying patient treatment.
Approximately 1,412 units have been distributed nationwide since May 1, 2023. Affected devices have part number 1067718 and unique device identification code UD-DI: 00812301020232. The device is manufactured by EBI, LLC and is indicated for treatment of established nonunion (bone fractures that have not healed) from trauma, excluding vertebrae and flat bones.
The specific hazard is that lead wire sheath damage could result in exposure of internal wires and failure to deliver the therapeutic treatment signal to electrodes, potentially resulting in delayed bone growth treatment for affected patients.
The recalled product
- Product
- Biomet 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
- Manufacturer
- EBI, LLC
- Hazard
- lead-wire-sheath-damage
- signal-delivery-failure
- treatment-delay
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)
- UD-DI: 00812301020232 All devices distributed since May 1
- 2023
Distribution
Distributed nationwide across the United States.
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