Biomet EBI Bone Healing System 1068238Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00812301020607), received between May 26, 2020 and Oct 23, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP ADVISED THAT THE PATIENT IS EXPERIENCING PAIN AFTER 4 HOURS WHILE USING THE BHS. THE PATIENT WAS CALLED AND ADVISED THAT SHE HAD ANKLE PAIN AND WORE IT FOR 10 HOURS. THE PATIENT DID NOT CALL THE DOCTOR, SHE CALLED THE SALES REP, WAS ADVISED TO DO A TIME TEST. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT AND SFLX COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23365983 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE VELCRO ON THE SFLX COILETTE HAS WORN OUT, PATIENT ALSO STATED THAT IT HURTS WHEN THEY WALK. THE SFLX COILETTE IS TOO FAT AND CAUSES A LOT OF PAIN WHILE WALKING. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 21843250 ↗
• InjuryMar 17, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED DISCOMFORT WHILE USING THE BHS ASSEMBLY. THE PATIENT INDICATED THAT THE AREA OF TREATMENT IS SORE AND HAS PAIN AFTER SHE USES THE STIM. THE PATIENT WORE THE UNIT FOR 6 TO 10 HOURS WHEN SHE HAD DISCOMFORT. THE PATIENT CONTACTED THEIR DOCTOR, AND THE PHYSICIAN ADVISED ONLY TO TREAT FOR 1 HOUR A DAY. THE PATIENT WAS GOING TO CONDUCT THE TIME-TEST AND CALL BACK IF THEY FACE ANY ISSUE. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT, SFLX COILETTE AND SFLX-XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21619594 ↗
• InjuryApr 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ELECTRIC SHOCK WHILE TREATING WITH THE BHS DEVICE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT LAST WEEK SHE EXPERIENCED A SHOCK TO THE LEFT FOOT. THE LEVEL OF PAIN COULD NOT BE REMEMBERED. THE PATIENT STOPPED USING THE UNIT. A REPLACEMENT BHS ASSEMBLY AND COILETTE WERE SHIPPED TO THE PATIENT'S HOME. THE PATIENT LATER REPORTED THAT SHE DOES NOT RECALL THE PAIN LEVEL, ONLY A SHOCKING SENSATION. THE PATIENT STATED THAT HER DOCTOR DID NOT RECOMMEND ANY MEDICAL INTERVENTION, ONLY TO CONTACT HER SALES REPRESENTATIVE TO OBTAIN A REPLACEMENT DEVICE. THE PATIENT STATED THE OLD BHS ASSEMBLY AND COILETTE HAVE BEEN MAILED BACK.

  Patient problems: Shock

  MAUDE report 19176055 ↗
• InjuryApr 11, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT MENTIONED THAT HER FOOT HAS STARTED TO HURT WHERE SHE HAS THE BHS. THE PATIENT SAID THE WORD THROBBING BUT THEN ALSO SAID SHE COULDN'T EXPLAIN THE FEELING. THE PATIENT WAS CALLED AND DESCRIBED THE FEELING AS A PULLING/BURNING SENSATION. THE PATIENT STATED THAT THE PAIN STARTED A COUPLE OF DAYS AGO. THE PATIENT STATED THAT THE PAIN IS ONLY WHILE SHE IS USING THE DEVICE. THE PATIENT STATED THAT IT IS LIKE A BURNING SENSATION/PRESSURE. THE PATIENT DOES NOT FEEL ANYTHING WHEN SHE IS NOT USING THE DEVICE. THE PATIENT HAS INCREASED HER DAILY ACTIVITY LATELY. THE PATIENT STATED THAT THE PAIN LEVEL IS 8 WHEN SHE IS NOT TAKING PAIN MEDICATION. THE PATIENT IS TAKING OXYCODONE 10/325. THE PATIENT IS GOING BACK TO THE DOCTOR ON THE 22ND. THE PATIENT IS USING THE DEVICE ABOUT 5 HOURS BECAUSE OF THE BURNING AND ACHING. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19091190 ↗
• InjurySep 28, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED HEADACHES AND HER WRIST HURT WHILE USING HER DEVICE. THE PAIN STARTED ON THE SECOND DAY AFTER SHE RECEIVED HER UNIT. THE PATIENT RATED THE PAIN AS AN 8 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT STATED THE PAIN GOES AWAY AFTER SHE STOPS WEARING THE UNIT. SHE ADVISED SHE DID NOT INCREASE HER DAILY ACTIVITIES. SHE CALLED HER DOCTOR AND HAD TO LEAVE A MESSAGE. THE PATIENT STATES SHE HAS A FRACTURED WRIST AND IS TAKING PAIN MEDICATION FOR THAT. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THE PATIENT TO CONDUCT A TIME TEST AND INCREASE THE TREATMENT TIME AS TOLERATED. THE PATIENT AGREED TO CALL CUSTOMER SERVICE BACK IF THERE WERE ANY ISSUES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17840005 ↗
• InjuryAug 22, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AND RISING BLOOD PRESSURE WHILE USING THE BHS DEVICE. THIS PATIENT WAS SWITCHED FROM A BONE HEALING ASSEMBLY TO AN ORTHOPAK ASSEMBLY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: High Blood Pressure/ Hypertension; Pain

  MAUDE report 17599941 ↗
• InjuryJun 10, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD PAIN AND DISCOMFORT FROM THE BHS UNIT. THE PATIENT USED THE DEVICE 10 HOURS AT NIGHT WHILE SLEEPING. DURING THE DAY SHE FELT DISCOMFORT IN HER FIRST AND SECOND TOE THAT WAS NOT CONSTANT BUT WAS AT TIMES A 7 OUT OF 10. THE PATIENT CLAIMS THIS FELT LIKE PAIN AND NERVES. THE PATIENT STATED THAT WHEN SHE BENT HER TOES THE PAIN WAS A 5 OUT OF 10. THIS PAIN WAS BELOW THE SURFACE OF THE SKIN. THE PATIENT CLAIMS SHE HAS NOT INCREASED HER PHYSICAL ACTIVITIES. THE PATIENT CLAIMS SHE HAS NOT SPOKEN TO ANY MEDICAL PROFESSIONAL ABOUT THIS PAIN. BUT THE SALES REPRESENTATIVE HAS REACHED OUT TO THE DOCTOR FOR HIS OPINION AND WILL UPDATE US AS SOON AS THEY HEAR BACK FROM THE DOCTOR. IT WAS LATER REPORTED BY THE PATIENT THAT THE SALES REPRESENTATIVE REACHED OUT TO HER DOCTOR REGARDING THE PAIN. THE PATIENT STATED THAT THE DOCTOR TOLD THE REPRESENTATIVE TO SWITCH THE PATIENT TO AN ORTHOPAK DEVICE DUE TO THE PAIN. THE PATIENT ALSO STATED THAT SHE WAS USING THE SFLX COILETTE TO TREAT.

  Patient problems: Pain

  MAUDE report 17102134 ↗
• InjuryDec 15, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BHS UNIT BURNED A HOLE IN THE PATIENT'S LEG WHICH CAUSE AN INFECTION THAT TOOK MONTHS TO HEAL. THE PATIENT CLAIMED THE "BUTTON" ON HIS COIL MUST HAVE HEATED UP AND BURNED HIS SKIN AND CAUSED A BLISTER. THE PATIENT REPORTED THAT HIS LEG FROM HIS ANKLE TO HIS KNEE WAS A RED INFECTED RASH. THE PATIENT CLAIMED HE HAS SENSITIVE SKIN AS HE IS A DIABETIC AND THE BLISTER TURNED INTO A "HOLE" IN HIS SKIN AND BEGAN TO BECOME INFECTED. THE PATIENT CLAIMED HE VISITED HIS ORTHOPEDIC DOCTOR WHO PRESCRIBED AN ORAL ANTIBIOTIC, AND THE REDNESS BEGAN TO SUBSIDE WITHIN THE FIRST 24 HOURS. THE PATIENT REPORTED THAT THE "HOLE" NEAR HIS ANKLE TOOK A COUPLE WEEKS TO FULLY HEAL. THE PATIENT STATED ANTIBIOTICS WERE FOR 7 DAYS, AND PATIENT DID NOT REFILL. THE PATIENT CLAIMED AT THE TIME THAT HIS PAIN WAS A 4 OUT OF TEN BUT HE ADVISED HE TAKES HYDROCODONE 3 TIMES PER DAY SO THAT SHOULD BE FACTORED INTO HIS ALREADY MANAGED PAIN. THE PATIENT WILL RETURN THE OLD PRODUCTS WITH THE RETURN LABEL SENT TO HIM. IT WAS REPORTED BY THE PATIENT THAT THE DOCTOR TOLD HIM HIS BONES WERE FUSED AND HE NO LONGER NEEDS TREATMENT.

  Patient problems: Blister; Burn(s); Pain; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 15988983 ↗
• InjuryAug 24, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION WHILE SHE WAS TREATING WITH THE BONE HEALING SYSTEM. THE PATIENT STATED THAT SHE HAS A COPPER ALLERGY. THE PATIENT¿S BHS CONTROLLER AND COIL MAKE HER FOOT SWELL UP AND CAUSE DISCOMFORT. IT WAS LATER REPORTED ON (B)(6) 2022, THAT THE PATIENT CONFIRMED THE COIL USED WAS A SLFX COILETTE. THE PATIENT FURTHER ADVISED SHE HAD A FULL BODY ALLERGIC REACTION TO THE BHS. THE SKIN ON HER WHOLE BODY WAS ITCHY. THE PATIENT DID NOT EXPERIENCE REDNESS, BLISTERS, WELTS, NO OTHER SKIN ISSUES, OR PAIN. THE PATIENT WAS ADVISED BY HER PHYSICIAN TO DISCONTINUE TREATMENT WITH THE BONE HEALING SYSTEM, AND SHE WOULD BE SWITCHED TO AN ORTHO PAK ASSEMBLY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 15289273 ↗
• InjuryNov 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IS COMPLAINING OF PAIN SINCE THEY STARTED TREATING WITH THE BHS UNIT. THE PATIENT WAS ADVISED TO STOP USING THE UNIT UNTIL THEY HEAR BACK FROM CUSTOMER SERVICE. THE PAIN STARTED A COUPLE OF HOURS AFTER USING THE DEVICE. THE PATIENT IS TREATING FOR 10 HOURS. WHEN THE PATIENT TAKES OFF THE STIMULATOR, THE PAIN STAYS THE SAME, BUT THE PAIN SUBSIDES WITHIN A COUPLE OF HOURS. THE PATIENT RATED THEIR PAIN AS A 9 ON A SCALE OF 1 TO 10, WHICH IS CONSIDERED SEVERE. THE PAIN IS BELOW THE SKIN. THE PATIENT HAS NOT INCREASED THEIR DAILY ACTIVITY. THE PATIENT HAD THEIR LAST SESSION OF PHYSICAL THERAPY ON (B)(6) 2021. THE PATIENT DID NOT CONTACT THEIR PHYSICIAN. THEY ARE NOT TAKING ANYTHING FOR THE PAIN. HE IS NOW EXPERIENCING PAIN WHEN WALKING. THE PATIENT WAS TOLD TO WAIT FOR A FEW DAYS OR A WEEK, THEN TO START DOING THE TIME TEST, BUT IF HE HAS PAIN AT ANY TIME TO STOP USING THE UNIT AND CONTACT THE SALES REP. THE PATIENT'S DOCTOR WAS ADVISED, AND THE PATIENT WAS SWITCHED TO A DIFFERENT DEVICE FOR TREATMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 12850091 ↗
• InjuryJan 31, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHILE USING THE BHS DEVICE. THE PATIENT SATED THAT SHE WAS UNSURE IF THE PAIN WAS CAUSED BY THE BHS OR NOT. THE PATIENT STATED THAT THE COIL IS PAINFUL TO WEAR ON CERTAIN PARTS OF THE FOOT. IT IS VERY SENSITIVE TO THE TOUCH. THE PATIENT WEARS A SOCK WHILE USING THE STIMULATOR. THE PAIN STARTED EVER SINCE SHE STARTED USING THE STIMULATOR. THE PATIENT JUST TOLERATED THE PAIN. THE PATIENT RATED THE PAIN AS A 8 OR 9 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PAIN IS ON THE SURFACE OF THE SKIN. THE PAIN SUBSIDES AFTER A WHILE WHEN SHE IS NOT USING THE UNIT. THE PATIENT STATED THAT SHE DOES NOT EXPERIENCE ANY PAIN WHILE USING THE BHS AT NIGHT. THE PATIENT HAS INCREASED HER DAILY ACTIVITY. THE PATIENT HAS NOT SEEN THE DOCTOR FOR A MONTH AND HE IS NOT AWARE THAT SHE IS HAVING PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 11256428 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THE MUSCLE SPASMS STARTED ABOUT A WEEK AFTER SHE STARTED USING THE MACHINE ON THE RIGHT FOOT. THE PAIN LEVEL WAS AN 8 OR 9. IT BEGAN ON HER FOOT AND WITHIN A FEW DATS IT WENT UP TO THE CALF OF THE RIGHT LEG. THE PAIN WAS BELOW THE SKIN. THERE WAS A BIG KNOT ON THE BACK OF THE RIGHT LEG. THE PAIN AND CRAMPING WENT AWAY BY THE NEXT DAY. THE PATIENT HAD INCREASED HER WALKING AND THEN 2 WEEKS LATER SHE RECEIVED THE BHS UNIT. THE PATIENT DID NOT SPEAK TO HER DOCTOR. I TOLD THE PATIENT TO DO A TIME TEST. THE PATIENT WILL START TOMORROW AFTER HER DOCTOR'S APPOINTMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 11084515 ↗
• InjuryMay 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND A BURNING SENSATION FROM USING THE BONE HEALING SYSTEM (BHS) WITH THE SFLX COILETTE. THE PATIENT WAS TREATING HER LEFT FOOT WITH THE DEVICE DURING THE NIGHT. THE PATIENT SAID THAT WHEN SHE FIRST STARTED TREATMENT, SHE WOULD WAKE UP IN PAIN AFTER 7 OR 8 HOURS. THE PATIENT REPORTED THAT THE PAIN WAS AN 8, ON A SCALE OF 1 TO 10. THE PATIENT DESCRIBED THE PAIN AS DEEP AND BELOW THE SURFACE OF THE SKIN. THE PATIENT SAID THAT THE PAIN SUBSIDES AFTER 30 TO 60 MINUTES AND THEN SHE CAN FALL BACK ASLEEP. A FEW DAYS LATER, AFTER 3 TO 5 HOURS OF TREATING, THE PATIENT WOKE FROM A SEARING BURNING SENSATION. THE PATIENT SAID THAT HER SKIN WAS NOT RED AND THE COILETTE WAS NOT HOT. THE PATIENT TRIED TREATING WITHOUT A SOCK UNDERNEATH THE COIL AND THE PATIENT STILL EXPERIENCED THE BURNING SENSATION. THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR AND WAS PROVIDED WITH A REPLACEMENT BHS CONTROLLER AND COILETTE FOR TREATMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burning Sensation; Pain

  MAUDE report 10086645 ↗