Biomet SpinalPak / OrthoPak 1067724-4Recalls & reported problems
Ebi, LLC · 48" LEAD WIRES, REPLACEMENT · Class 2
All models of Biomet SpinalPak / OrthoPak (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812301020324), received between Nov 7, 2024 and Nov 7, 2024 — classified as 2 injuries.
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (P850022); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 22, 2024Class IIOpen, Classified
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
Z-1619-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE LEAD WIRE PRESSING UP AGAINST HER SKIN INSIDE OF HER ORTHOPEDIC BOOT. THE PATIENT STATED THAT THE LEAD WIRE SPLIT UP THE MIDDLE AND BECAME DISORGANIZED WITHIN HER BOOT, LEADING TO MORE WIRES PRESSED UP AGAINST HER SKIN. THE PATIENT WAS SENT A WARRANTY SPINALPAK UNIT BECAUSE THE ORTHOPAK UNIT WAS AT END OF OPERATION. NO FURTHER CONSEQUENCES OR FURTHER INFORMATION WAS RECEIVED. THE LEAD WIRE WAS NOT RETURNED FOR FURTHER EVALUATION.
Patient problems: Pain
MAUDE report 20631646 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM THE LEAD WIRE PRESSING UP AGAINST HER SKIN INSIDE OF HER ORTHOPEDIC BOOT. THE PATIENT STATED THAT THE LEAD WIRE SPLIT UP THE MIDDLE AND BECAME DISORGANIZED WITHIN HER BOOT, LEADING TO MORE WIRES PRESSED UP AGAINST HER SKIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE 48" LEAD WIRE WAS RETURNED FOR FURTHER EVALUATION.
Patient problems: Pain
MAUDE report 20631461 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P850022. One submission often covers many models, so check the product and lot details in each record.
- Z-1616-2024 · Mar 22, 2024 · Open, ClassifiedBiomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat
- Z-1617-2024 · Mar 22, 2024 · Open, ClassifiedBiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bon
- Z-1618-2024 · Mar 22, 2024 · Open, Classified20" Lead Wires, Replacement Part Number: 1067724-2
Other Stimulator, Bone Growth, Non-Invasive devices
- Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall1 death262 reports
- Biomet SpinalPak / OrthoPak 106130-20Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 death188 reports
- Biomet EBI Bone Healing System 1068234Ebi, LLC · Stimulator, Bone Growth, Non-Invasive171 reports
- Biomet SpinalPak / OrthoPak 106130-22Ebi, LLC · Stimulator, Bone Growth, Non-Invasive101 reports
- Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall41 reports
- Biomet EBI Bone Healing System 1068240Ebi, LLC · Stimulator, Bone Growth, Non-Invasive61 reports
- Biomet SpinalPak / OrthoPak 1067724-2Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall4 reports
- Biomet SpinalPak / OrthoPak 106130-17Ebi, LLC · Stimulator, Bone Growth, Non-Invasive52 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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