Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067719Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812301020249), received between Apr 28, 2020 and Apr 28, 2020 — 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

Recent adverse event reports

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

• InjuryApr 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WITH THE ORTHOPAK STIMULATOR. THE PATIENT SAID THAT BEFORE USING THE STIMULATOR, HER PAIN WAS A 3 ON A SCALE OF 1-10, WITH 10 BEING THE HIGHEST. THE FIRST TIME THE PATIENT USED THE STIMULATOR SHE HAD USED IT FOR TWO HOURS. THE PATIENT SAID THAT SHE EXPERIENCED AN ICY HOT SENSATION THAT TRANSITIONED INTO A DEEP BONE PAIN. THE PATIENT RATED THE PAIN AS A 7 OR 8. THE PATIENT STOPPED WEARING THE UNIT AND THE PAIN DID NOT GO AWAY FOR TWO DAYS. THE PATIENT DID CONTACT HER DOCTOR. THE DOCTOR ADVISED THE PATIENT TO BREAK UP THE TIME THAT SHE TREATS WITH THE UNIT AND TO TAKE TYLENOL. THE PATIENT REPORTED THAT HER PAIN WAS AT A 5 OR 6. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 10004301 ↗

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