CMF OL1000 Dual CoilRecalls & reported problems
Djo, LLC · The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912011488), received between Jul 19, 2019 and Jun 17, 2026 — classified as 2 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Burn(s)1
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 56-YEAR-OLD MALE PRESENTS TO URGENT CARE WITH A OPEN SORE ON HIS LEFT FOOT A T WEEK AFTER HE USED HIS STIMULATOR ON THE AREA. PATIENT WAS SEEING WOUND CENTER FOR AN OPEN SORE IN THE AREA BUT WAS DISCHARGED RECENTLY.
Patient problems: Burn(s)
MAUDE report 25538355 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT "HAD AN ADVERSE REACTION TO THE CMF OL1000." PATIENT'S ORTHOPEDIC DOCTOR PRESCRIBED THIS UNIT FOR A NON-UNION FIBULA-ANKLE BREAK. PATIENT USED IT FOR SIX, 30-MINUTE TREATMENTS. AFTER THE FIFTH & SIXTH TREATMENTS, HER ANKLE BECAME INCREDIBLY CONSTRICTED AND NUMB. THE NUMBNESS HAS ALSO INVOLVED THE BOTTOM & TOP OF HER FOOT, CALF, AND THIGH. PATIENT DISCONTINUED USAGE IMMEDIATELY & INFORMED HER DOCTOR. THE CONSTRICTION/NUMBNESS HAS REPORTEDLY NOT DISSIPATED. PATIENT CAN BARELY WALK DUE TO THE NUMBNESS.
Patient problems: Numbness
MAUDE report 8809318 ↗
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 1067724-4Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall2 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page