Skip to content

Biomet SpinalPak / OrthoPak 1067724-5Recalls & reported problems

Ebi, LLC · 72" LEAD WIRES, REPLACEMENT · 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 00812301020331), received between Dec 16, 2021 and Dec 16, 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
  • Swelling/ Edema1

Recent adverse event reports

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

  • InjuryDec 16, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

    IT WAS REPORTED BY THE PATIENT THAT SHE WAS HAVING AN IRRITATION WITH HER 72R ELECTRODES. THE PATIENT CLAIMS HER SKIN WAS RED AND ITCHY WITH SWELLING AND BLISTERS. THE IRRITATION WAS UNDER THE ELECTRODE, BUT IT THEN SPREAD BEYOND THE SHAPE OF THE ELECTRODE. THE PATIENT ROTATED THE ELECTRODES EVERY 12 HOURS, AND SHE CLEANED THE AREA WITH SOAP AND WATER AND A WASH CLOTH. THE PATIENT DID NOT USE WIPES. THE PATIENT CLAIMS SHE NORMALLY DOES HAVE SENSITIVE SKIN AND IS TYPICALLY ALLERGIC TO ADHESIVES, DISSOLVING STITCHES, MIXED METALS, AND SOME INSECTS, INCLUDING SPIDERS. THE PATIENT DENIES SEASONAL ALLERGIES AND HAS NOT CHANGED THE USE OF ANY PRODUCTS RECENTLY. THE PATIENT DOES TAKE BLOOD PRESSURE MEDICATION. THE PATIENT SOUGHT THE ADVICE OF HER SURGEON, WHO ADVISED HER TO DISCONTINUE TREATMENT AND SEEK ALTERNATIVES WITH ZIMMER BIOMET. 63B ELECTRODES WERE BEEN SENT TO THE PATIENT TO TRY A DIFFERENT TYPE OF ELECTRODE. THE PATIENT WILL FOLLOW A TIME TEST AFTER HER SKIN HAS CLEARED. IT WAS LATER REPORTED THAT THE DOCTOR TOLD THE PATIENT TO TRY USING THE 63B ELECTRODES ON HER BACK WHEN THE SKIN IS HEALED. THE PATIENT ALSO STATED THAT THE DOCTOR TOLD HER TO STOP TREATMENT IF THE IRRITATION HA

    Patient problems: Blister; Skin Inflammation/ Irritation; Swelling/ Edema

    MAUDE report 13022357 ↗

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-1619-2024 · Mar 22, 2024 · Open, Classified
    48" Lead Wires, Replacement Part Number: 1067724-4
  • 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-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

How reports and recalls are matched · Editorial policy · Report an error on this page