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Biomet SpinalPak / OrthoPak 1067728-1Recalls & reported problems

Ebi, LLC · WALL PLUG ADAPTER KIT · Class 2

All models of Biomet SpinalPak / OrthoPak (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812301020379), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 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.

Most reported problems

Device problems

  • Insufficient Device Problem Information1
  • Patient-Device Incompatibility1

Patient problems

  • Blister1
  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 5, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT IS STATING ELECTRODES (NOT COVER PATCHES) ARE LEAVING BLISTERS DIRECTLY UNDERNEATH THE PADS THAT ARE SEEPING FLUID. ADVISED THE PATIENT TO TAKE THE DEVICE OFF FOR 4-5 DAYS UNTIL SKIN IS COMPLETELY CLEARED UP. PATIENT IS ROTATING PADS AS WELL. CALLED THE PATIENT BACK. PATIENT STATED THEY WERE CAUSING BLISTERS. BOTH SIDES HAD BLISTERS AND BROKE. WENT TO DOCTOR AND ADVISED HIM TO ROTATE. WORE THE 72R ELECTRODES COVER WITH A BRACE. HE CHANGES THEM EVERY 2 DAYS. HE STILL WANTED TO USE THE 72R. ADVISED TO CHANGE ELECTRODES 2 TIMES A DAY WITH ROTATION AND NO COVERS. STATED HE WILL CALL BACK IF HE HAS ANY MORE ISSUES. SAID HE WILL SEND OUT THE 63B ELECTRODES IF THE 72R ELECTRODES CONTINUE TO CAUSE IRRITATION. NEW 72R AND 63B ELECTRODES WERE SHIPPED TO THE PATIENT.

    Patient problems: Blister; Skin Inflammation/ Irritation

    MAUDE report 11776096 ↗

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, Classified
    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
  • Z-1618-2024 · Mar 22, 2024 · Open, Classified
    20" Lead Wires, Replacement Part Number: 1067724-2
  • Z-1619-2024 · Mar 22, 2024 · Open, Classified
    48" Lead Wires, Replacement Part Number: 1067724-4
  • Z-1617-2024 · Mar 22, 2024 · Open, Classified
    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 bon

Other Stimulator, Bone Growth, Non-Invasive devices

All Stimulator, Bone Growth, Non-Invasive devices →

Sources and updates

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