Biomet EBI Bone Healing SystemRecalls & reported problems across all models
Ebi, LLC · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 327
- Deaths reported
- 0
- Injuries reported
- 327
- Recalls
- 0
We found 12 models of Biomet EBI Bone Healing System by Ebi, LLC in the FDA's device registry (GUDID). Together they are named in 327 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2019 and Jun 22, 2026 — classified as 327 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (139 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Biomet EBI Bone Healing System problems
Device problems
- Adverse Event Without Identified Device or Use Problem195
- Patient-Device Incompatibility139
- Insufficient Device Problem Information136
- Overheating of Device7
- Appropriate Device Problem Term/Code Not Available6
- Device-Device Incompatibility1
- Off-Label Use1
- Patient Device Interaction Problem1
Patient problems
- Pain288
- Burning Sensation31
- Swelling/ Edema25
- Burn(s)15
- Shock14
- Numbness12
- Discomfort11
- Skin Inflammation/ Irritation11
Biomet EBI Bone Healing System models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biomet EBI Bone Healing System 1068234Stimulator, Bone Growth, Non-Invasive171 reports
- Biomet EBI Bone Healing System 1068240Stimulator, Bone Growth, Non-Invasive61 reports
- Biomet EBI Bone Healing System 1068226Stimulator, Bone Growth, Non-Invasive27 reports
- Biomet EBI Bone Healing System 1068229Stimulator, Bone Growth, Non-Invasive20 reports
- Biomet EBI Bone Healing System 1068238Stimulator, Bone Growth, Non-Invasive14 reports
- Biomet EBI Bone Healing System 1068225Stimulator, Bone Growth, Non-Invasive12 reports
- Biomet EBI Bone Healing System 1068235Stimulator, Bone Growth, Non-Invasive11 reports
- Biomet EBI Bone Healing System 1068224Stimulator, Bone Growth, Non-Invasive3 reports
- Biomet EBI Bone Healing System 1068239Stimulator, Bone Growth, Non-Invasive3 reports
- Biomet EBI Bone Healing System 1068228Stimulator, Bone Growth, Non-Invasive2 reports
- Biomet EBI Bone Healing System 1068233Stimulator, Bone Growth, Non-Invasive2 reports
- Biomet EBI Bone Healing System 1068227Stimulator, Bone Growth, Non-Invasive1 report
Recent Biomet EBI Bone Healing System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
THE SALES REP ADVISED THAT THE PATIENT HAD PAIN WHILE USING THE BHS. THE PATIENT WAS CALLED TO COLLECT ADDITIONAL INFORMATION BUT A VOICEMAIL HAD TO BE LEFT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.
Patient problems: Pain
MAUDE report 25580370 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THEIR FRACTURE SITE WHEN DURING TREATMENT WITH THE DEVICE. IT WAS LATER REPORTED THAT AFTER CONDUCTING A TIME TEST, THE PATIENT CONTINUED TO EXPERIENCE PAIN. THE PATIENT STATED THAT THE PAIN STARTS ABOUT AFTER 2 HOURS OF TREATMENT AND RATED THE PAIN LEVEL A 5 OUT OF 10. THE PATIENT STATED THAT AT APPROXIMATELY 3 HOURS OF TREATMENT, THE PAIN BECOMES UNBEARABLE AND INCREASES TO A 10 OUT OF 10. AT THIS POINT THE PATIENT REMOVES THE DEVICE. THE PATIENT STATED THAT THE PAIN IS ONLY AT THE FRACTURE SITE, THERE IS NO REDNESS OR SWELLING IN THE AREA. THE PATIENT DISCUSSED THE ISSUE WITH THEIR DOCTOR BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WILL CONTINUE TREATMENT AND LIMIT TREATMENT PERIODS TO 3 HOURS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 25334517 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THEIR FRACTURE SITE WHEN DURING TREATMENT WITH THE DEVICE. IT WAS LATER REPORTED THAT AFTER CONDUCTING A TIME TEST, THE PATIENT CONTINUED TO EXPERIENCE PAIN. THE PATIENT STATED THAT THE PAIN STARTS ABOUT AFTER 2 HOURS OF TREATMENT AND RATED THE PAIN LEVEL A 5 OUT OF 10. THE PATIENT STATED THAT AT APPROXIMATELY 3 HOURS OF TREATMENT, THE PAIN BECOMES UNBEARABLE AND INCREASES TO A 10 OUT OF 10. AT THIS POINT THE PATIENT REMOVES THE DEVICE. THE PATIENT STATED THAT THE PAIN IS ONLY AT THE FRACTURE SITE, THERE IS NO REDNESS OR SWELLING IN THE AREA. THE PATIENT DISCUSSED THE ISSUE WITH THEIR DOCTOR BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WILL CONTINUE TREATMENT AND LIMIT TREATMENT PERIODS TO 3 HOURS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 25334506 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING. THE PATIENT ADVISED THAT THEY HAD ALWAYS HAD THE DISCOMFORT AND SWELLING, BUT LATELY IT HAD BEEN WORSE. THE PATIENT STATED THAT THEIR USUAL DISCOMFORT WAS RATED 6 OUT OF 10, AND WHEN PUTTING WEIGHT ON THE FOOT THE DISCOMFORT IS AN 8 OUT OF 10. THE PATIENT STATED THAT SOME DAYS THEY DID NOT TREAT WITH THE BONE HEALING SYSTEM DEVICE AT ALL BECAUSE THE SFLX 3 COIL PUTS PRESSURE ON THEIR SWOLLEN TENDON. THE PATIENT NOTED THAT THEIR LEVEL OF ACTIVITY HAD NOT CHANGED RECENTLY BUT STATED THAT THEY BEGAN PUTTING WEIGHT ON THEIR FOOT APPROXIMATELY 3 WEEKS AGO. THE PATIENT BEGAN TAKING APPROXIMATELY 10 STEPS PER DAY, THEN RETURNING TO THE WHEELCHAIR. THE PATIENT¿S DOCTOR REQUESTED THAT THE PATIENT BE SWITCHED TO ANOTHER BONE GROWTH STIMULATOR AS THE PATIENT HAD NOT HAD ANY BONE GROWTH. AN ORTHOPAK DEVICE WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort; Swelling/ Edema
MAUDE report 25230637 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING. THE PATIENT STATED THAT THEIR USUAL DISCOMFORT WAS RATED 6 OUT OF 10, AND WHEN PUTTING WEIGHT ON THE FOOT THE DISCOMFORT IS AN 8 OUT OF 10. THE PATIENT STATED THAT SOME DAYS THEY DID NOT TREAT WITH THE BONE HEALING SYSTEM DEVICE AT ALL BECAUSE THE SFLX 3 COIL PUTS PRESSURE ON THEIR SWOLLEN TENDON. THE PATIENT NOTED THAT THEIR LEVEL OF ACTIVITY HAD NOT CHANGED RECENTLY BUT STATED THAT THEY BEGAN PUTTING WEIGHT ON THEIR FOOT APPROXIMATELY 3 WEEKS AGO. THE PATIENT BEGAN TAKING APPROXIMATELY 10 STEPS PER DAY, THEN RETURNING TO THE WHEELCHAIR. THE PATIENT¿S DOCTOR REQUESTED THAT THE PATIENT BE SWITCHED TO ANOTHER BONE GROWTH STIMULATOR AS THE PATIENT HAD NOT HAD ANY BONE GROWTH. AN ORTHOPAK DEVICE WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort; Swelling/ Edema
MAUDE report 25230633 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT¿S FOOT HURT DURING TREATMENT. THE PATIENT STATED THAT THE PAIN STARTED A FEW DAYS AFTER RECEIVING THE UNIT. THE PATIENT RATED THE PAIN LEVEL A 12 OUT OF 10 WITH 10 BEING THE HIGHEST. THE PAIN SUBSIDED WHEN THE PATIENT PAUSED TREATMENT. THE PATIENT DID NOT DISCUSS THE ISSUE WITH THEIR DOCTOR AND IS TAKING IBUPROFEN FOR THE PAIN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 25159082 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT¿S FOOT HURT WHILE TREATING WITH THE BIOMET EBI BONE HEALING SYSTEM. THE PATIENT STATED THAT THE PAIN STARTED A FEW DAYS AFTER RECEIVING THE UNIT. THE PATIENT RATED THE PAIN LEVEL A 12 OUT OF 10 WITH 10 BEING THE HIGHEST. THE PAIN SUBSIDED WHEN THE PATIENT WAS NOT TREATING. THE PATIENT DID NOT DISCUSS THE ISSUE WITH THEIR DOCTOR AND IS TAKING IBUPROFEN FOR THE PAIN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 25159064 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S MOTHER REPORTED THAT THEIR ANKLE HAS BEEN SWOLLEN SINCE STARTING TO TREAT WITH THE DEVICE. THE COIL IS NOT TOO TIGHT. ON (B)(6) 2026, THE PATIENT¿S MOTHER SPOKE TO CUSTOMER SERVICE AND STATED HER SON HAD SWELLING AND PAIN, AND HE WAS NOT ABLE TO WALK. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITIES. THE PATIENT WORKS AND STANDS. THE PATIENT USED ICE ON HIS FOOT AND TOOK IBUPROFEN. THEY DID NOT CALL THE DOCTOR. THE PAIN LEVEL WAS A 10, AND THE PATIENT COULD BARELY WALK. THE PATIENT WILL CONDUCT THE TIME TEST AND CAN CALL BACK IF THERE ARE ANY ISSUES. NO REPLACEMENT PRODUCT WAS SHIPPED. NO FURTHER CONSEQUENCES ARE REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24845665 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED EXPERIENCING PAIN WHILE TREATING. THE SALES REP ADVISED THE PATIENT TO STOP WEARING THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY WAS NOT RETURNED.
Patient problems: Pain
MAUDE report 24616629 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT HE IS IN PAIN. IT FEELS LIKE A NEEDLE INSIDE. IT IS A BURNING PAIN AND THE PAIN LEVEL IS WAY OVER 10. THE SKIN IS RED. THE SKIN IS SLIGHTLY WARMER THAN THE REST OF HIS BODY. ON WEDNESDAY IT LOOKED LIKE RED DOTS. TODAY IT LOOKS VERY RED ON THE AREA. THE PATIENT STARTED ABOUT 2 MONTHS AGO. THE PATIENT DID MENTION THIS TO HIS DOCTOR AND THE DOCTOR TOLD HIM THIS WAS THE HEALING PROCESS. THE PAIN IS ONLY WHEN HE IS WEARING THE UNIT. WHEN HE TAKES IT OFF THE PAIN DIMINISHES AND GOES AWAY AFTER AN HOUR OR SO. THE AREA THAT IS RED GETS IRRITATED WHEN HE IS WEARING HIS SHOES. THE CUSTOMER SERVICE REPRESENTATIVE OFFERED TO REPLACE HIS UNIT AND COIL AND THE PATIENT DECLINED SAYING HE DOES NOT WANT TO DELAY THE HEALING. HE ALSO WANTED TO REVIEW THE PLACEMENT OF THE COIL. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED SHE WOULD HAVE HIS SALES REPRESENTATIVE (B)(6) CALL HIM REGARDING THIS ISSUE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED (B)(6) AND EXPLAINED THE PATIENT'S ISSUE. SHE ADVISED NOT TO SEND ANY NEW PRODUCT AS SHE WILL CONTACT THE PATIENT AND ADVISE HIM TO VISIT THE DOCTOR. (B)(6) NOTED THIS MAY BE A NEW MEDICAL ISSUE SINCE THERE WAS NO PAIN FOR OVER A
Patient problems: Pain
MAUDE report 24344121 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT HE IS IN PAIN. IT FEELS LIKE A NEEDLE INSIDE. IT IS A BURNING PAIN AND THE PAIN LEVEL IS WAY OVER 10. THE SKIN IS RED. THE SKIN IS SLIGHTLY WARMER THAN THE REST OF HIS BODY. ON WEDNESDAY IT LOOKED LIKE RED DOTS. TODAY IT LOOKS VERY RED ON THE AREA. THE PATIENT STARTED ABOUT 2 MONTHS AGO. THE PATIENT DID MENTION THIS TO HIS DOCTOR AND THE DOCTOR TOLD HIM THIS WAS THE HEALING PROCESS. THE PAIN IS ONLY WHEN HE IS WEARING THE UNIT. WHEN HE TAKES IT OFF THE PAIN DIMINISHES AND GOES AWAY AFTER AN HOUR OR SO. THE AREA THAT IS RED GETS IRRITATED WHEN HE IS WEARING HIS SHOES. THE CUSTOMER SERVICE REPRESENTATIVE OFFERED TO REPLACE HIS UNIT AND COIL AND THE PATIENT DECLINED SAYING HE DOES NOT WANT TO DELAY THE HEALING. HE ALSO WANTED TO REVIEW THE PLACEMENT OF THE COIL. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED SHE WOULD HAVE HIS SALES REPRESENTATIVE (B)(6) CALL HIM REGARDING THIS ISSUE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED (B)(6) AND EXPLAINED THE PATIENT'S ISSUE. SHE ADVISED NOT TO SEND ANY NEW PRODUCT AS SHE WILL CONTACT THE PATIENT AND ADVISE HIM TO VISIT THE DOCTOR. (B)(6) NOTED THIS MAY BE A NEW MEDICAL ISSUE SINCE THERE WAS NO PAIN FOR OVER A
Patient problems: Pain
MAUDE report 24344003 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN AFTER FIVE HOURS OF TREATMENT. THE PATIENT WILL COMPLETE THE TIME TEST, STARTING AT 4 HOURS PER DAY FOR 2 DAYS. INCREASING BY AN HOUR EVERY TWO DAYS. IT WAS LATER REPORTED THAT THE PATIENT STOPPED EXPERIENCING PAIN AFTER REDUCING TREATMENT TIME. THE PATIENT TREATS DURING THE DAY AND REMOVES THE DEVICE AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 24086158 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS PAIN WHEN WEARING THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain
MAUDE report 24024135 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THEIR FOOT AND STATED THAT THEIR FOOT FELT LIKE IT WAS BURNING. IT WAS LATER REPORTED THAT THE SFLX 2 COIL GIVES THE PATIENT A BURNING SENSATION ON THEIR FOOT. SOME NIGHTS THE BURNING SENSATION IS RATED AT A 10 OUT OF 10. AFTER TREATING AT NIGHT, THE PATIENT RATED THE BURNING SENSATION A 3 OUT OF 10. THE PATIENT SHARED THEY ARE STILL WEARING THE BOOT WHILE TREATING EVEN THOUGH THE DOCTOR TOLD THEM THEY DO NOT NEED TO. THE PATIENT DID NOT DISCUSS THE BURNING SENSATION WITH THEIR DOCTOR AND DID NOT USE ANY CREAMS. THE SKIN IS RED AND PAINFUL WITH NO BLISTERS AND NO BUMPS. THE PATIENT NORMALLY USES THE DEVICE STARTING AROUND 10PM AND WAKES UP FEELING THE BURN BY 3-5 AM EVERY NIGHT. THE PATIENT NOTED THAT THERE WERE NO ISSUES WITH THE ORIGINAL SFLX 2 COIL RECEIVED IN THE ASSEMBLY, THE BURNING SENSATION BEGAN WITH THE REPLACEMENT SFLX 2 COIL. A NEW SLFX 2 COIL WAS SHIPPED TO THE PATIENT.
Patient problems: Pain; Skin Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 23990049 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED SHE WAS IN A LOT OF PAIN WHILE TREATING. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 5 HOURS. THEN TOOK A BREAK FOR A FEW HOURS. THEN WORE IT AGAIN FOR 90 MINUTES AND BEGAN FEELING PAIN. THE PATIENT DID NOT TELL THE DOCTOR, ONLY THE SALES REP. THE PATIENT WILL CONDUCT THE TIME TEST AND CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURN FOR FURTHER EVALUATION.
Patient problems: Pain
MAUDE report 23961422 ↗
Other Ebi, LLC products
All Ebi, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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