Biomet EBI Bone Healing System 1068225Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00812301020508), received between Feb 4, 2020 and Nov 21, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S LEG WENT NUMB WITHIN THE FIRST 5 MINUTES OF TREATMENT. THE NUMBNESS RESOLVED ON ITS OWN WITHIN 5 TO 10 MINUTES OF REMOVING THE DEVICE. THE PATIENT CONTACTED THEIR PHYSICIAN AND WAS SWITCHED FROM THE BONE HEALING SYSTEM TO THE ORTHOPAK FOR TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Numbness

  MAUDE report 23619293 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AND THE UNIT GETTING VERY WARM TO THE TOUCH. THE PATIENT HAD BEEN USING THE DEVICE FOR 2 WEEKS WHEN SHE STARTED TO FEEL A LOT OF PAIN, THE AREA SHE WAS TREATING FELT REALLY HOT, AND HER HAND SWELLED. THE PATIENT COMPARED THE FEELING TO THE PULSING PAIN THAT OCCURS AFTER SMASHING ONE¿S FINGER IN A DOOR. THE PATIENT NOTED THAT THEY USE THE DEVICE AT NIGHT SO IT MAKES IT VERY HARD TO SLEEP. THE PATIENT CONTACTED THEIR DOCTOR BUT WAS ADVISED TO REACH OUT TO THE SALES REPRESENTATIVE. IT WAS LATER REPORTED THAT THE PAIN AND SWELLING OCCUR WITHIN AN HOUR OF USING THE DEVICE. THE PAIN LEVEL IS AT AN 8 OR 9 OUT OF 10. THERE WAS ONE DAY THE PATIENT DID NOT USE THE UNIT AND SHE HAD NO PAIN OR SWELLING. A REPLACEMENT CONTROLLER AND SFLX 1 COIL WERE SENT TO THE PATIENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20902508 ↗
• InjuryNov 27, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT FELT SOME PAIN AND HEAT. THE DOCTOR TOOK THE CAST OFF AND THERE WAS A BLISTER. THE DOCTOR ADVISED NOT TO TREAT FOR A FEW DAYS. LATER THE PATIENT INDICATED THAT THEY FELT NUMBNESS AND HEAT- "LIKE THEIR HAND IS ON FIRE" WHICH WAS ASSOCIATED WITH PAIN LEVEL OF 8-9 ON A SCALE OF 1-10, 10 BEING THE WORST. THEY FELT THE PAIN FOR 20-30SEC AND REMOVED THE DEVICE. THE PATIENT CONTACTED THEIR DOCTOR WHO ADVISED TO STOP USING THE UNIT FOR FEW DAYS AND TRY IS AGAIN. THE PATIENT STARTED USING THE DEVICE NOW BUT HE IS STILL FEELING NUMBNESS AND TINGLING IN HIS RIGHT HAND AFTER FEW HOURS OF TREATMENT, NO PAIN OR BURNING SENSATION. THE DOCTOR DID NOT PRESCRIBE ANY MEDICATIONS. NO FURTHER CONSEQUENCES WERE REPORTED. THE SFLX-1 COIL WAS NOT RETURNED FOR EVALUATIONS.

  Patient problems: Blister; Pain

  MAUDE report 20800096 ↗
• InjuryOct 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN WHILE USING BHS UNIT. LATER, THE PATIENT WAS CONTACTED AGAIN FOR ADDITIONAL INFORMATION AND STATED THAT THE SFLX-1 COIL STRAP WAS CAUSING PAIN AS THE PATIENT HAD TO TIGHTEN THE STRAP TO KEEP IT FROM FALLING OFF. THE PATIENT CONTACTED THEIR PHYSICIAN AND THE DOCTOR ADVISED TO SWITCH TO ORTHOPAK UNIT. NO FURTHER INFORMATION HAS BEEN REPORTED. THE SFLX-1 COIL HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 20384659 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING A LOT OF PAIN AND DISCOMFORT. THE SALES REPRESENTATIVE GAVE THE PATIENT A LOT OF TRIAL-AND-ERROR OPTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 19623373 ↗
• InjuryOct 20, 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 CLAIMS WHILE TREATING WITH THE BHS DEVICE FOR HER RIGHT FOOT FOR THE 2 AND 3 METATARSALS THAT THE 4TH AND 5TH METATARSAL HAS BEGUN TO AUTO FUSE WHILE CAUSING HER A "STIFF" FEELING. THE PATIENT CLAIMED THE PAIN IS UNDER THE SURFACE OF THE SKIN AND DOES NOT SUBSIDE WHEN TREATMENT IS OVER. THE PATIENT REPORTED SHE HAS HAD PHYSICAL THERAPY SINCE HER SURGERY ON (B)(6) 2021. THE PATIENT STATES WHILE USING THE FLEX 1 COIL FOR ALMOST 2 MONTHS, THE PATIENT COMPLAINED TO HER DOCTOR THAT HER FOOT WAS STIFF, AND SHE HAD A PAIN LEVEL OF 8 OUT OF TEN. THE PATIENT STATED THAT HER DOCTOR FURTHER INVESTIGATED WITH AN X-RAY THAT WHILE TREATING HER 2 AND 3 METATARSALS ARTHRITIS IN HER 4 AND 5 METATARSALS HAS STARTED TO FUSE. THE PATIENT COMPLAINED OF HAVING TO WEAR HER BONE STIMULATOR FOR 10 HOURS. THE PATIENT REPORTED THAT THE DOCTOR ADVISED THAT SHE TREAT WITH THE STIMULATOR WITH A SMALLER COIL TO FOCUS MORE CLOSELY ON THE 2 AND 3 METATARSALS AND TREAT ONLY 2 HOURS PER DAY. IT WAS REPORTED BY THE PATIENT THAT SHE WAS PRESCRIBED WATER THERAPY FOR THE PAIN SHE EXPERIENCED WHILE USING HER UNIT. THE PATIENT WISHES TO RETURN THE 2 LARGER COILS SHE NO LONGER USES IN THE P

  Patient problems: Pain

  MAUDE report 15638649 ↗
• InjuryAug 24, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE TREATING WITH THE BONE HEALING SYSTEM. THE PATIENT WORE THE DEVICE OVERNIGHT FOR ABOUT 8 HOURS. A FEW HOURS INTO THE TREATMENT, SHE STARTED TO FEEL A VERY SHARP PAIN INSIDE THE ANKLE. THIS PAIN CAME THROUGHOUT THE NIGHT AND WOKE HER UP SEVERAL TIMES. SHE TOOK OFF THE BHS AND THE PAIN SUBSIDED. THE PATIENT ADVISED HER FOOT IS BROKEN IN 4-YEAR PLACES. THE ZIMVIE SALES REPRESENTATIVE ADVISED HER TO STOP USING ANY TIME SHE FEELS PAIN OR DISCOMFORT. SHE PLANS TO TRY THIS APPROACH FOR A FEW DAYS AND WILL CALL CUSTOMER SERVICE TO UPDATE THEM. SHE IS AWARE SHE WILL BE CALLED FOR MORE INFORMATION. IT WAS LATER REPORTED ON (B)(6) 2022, THE PATIENT QUANTIFIES AS 7 OUT OF 10 AND UNDER THE SURFACE OF THE SKIN AND IN HER JOINT. THE PATIENT'S DOCTOR HAS REQUESTED THAT THE PATIENT BE SWITCHED TO THE ORTHOPAK. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15287862 ↗
• InjuryFeb 2, 2022Adverse 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 THAT THE PHYSICIAN OF THE PATIENT FELT A "SHOCK" WHILE USING HER BONE STIMULATOR. THE PATIENT THEN SAW A BLISTER ON THE LATERAL SIDE OF HER ANKLE. THE PATIENT STATED THAT IT HAPPENED ONCE. THERE WAS A LITTLE BLISTER, AND THE PATIENT PUT A BAND-AID ON IT. THE DOCTOR PRESCRIBED ANTIBIOTICS, DOXYCYCLUNE HYCLATE 100MG, TWICE A DAY FOR 10 DAYS. THE PATIENT WAS TOLD TO PUT ANTIBIOTIC OINTMENT ON THE AREA. THE PATIENT FELT AN ELECTRICAL SHOCK ON THE BONE. THE PAIN LEVEL WAS A 7 ON THE SURFACE OF THE SKIN. THE BLISTER IS HEALING RIGHT NOW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. THE COIL WAS LATER RETURNED FOR EVALUATION.

  Patient problems: Pain; Shock

  MAUDE report 13431848 ↗
• InjuryJul 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE DEVICE THAT SHE IS WEARING ON HER FOOT IS CAUSING PAIN IN HER LEGS. I EXPLAINED THAT THE DEVICE SHOULD NOT HAVE ANY EFFECT ON HER LEGS BUT SHE SAYS SHE IS SCARED TO CONTINUE WEARING THE DEVICE. SPOKE TO THE PATIENT'S HUSBAND WHO STATED THAT THE PAIN STARTED THE SECOND DAY AFTER STARTING HER TREATMENT WITH THE STIMULATOR. THE PAIN AFTER THE SECOND NIGHT OF WEARING THE UNIT FOR 10 HOURS. THE PAIN LEVEL WAS A 10. THE PATIENT IS USING THE COIL ON HER LEFT FOOT. THE PATIENT COULD NOT STAND FROM THE PAIN ON THE SHIN (FRONT OF THE LEG) ON BOTH LEGS. THE PAIN IS STILL THERE ON BOTH LEGS. THE PAIN LEVEL IS RIGHT NOW AT A 7 OR 8. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PATIENT CALLED THE DOCTOR'S OFFICE SPOKE TO A SECRETARY WHO TOLD THE PATIENT TO CONTACT THE SALES REP. THE PATIENT STATED THAT SHE CONTACTED THE SALES REP BEFORE SHE CALLED THE DOCTOR. THE PATIENT IS TAKING NORCO 5/325MG EVERY 6 HOURS AS NEEDED FOR PAIN. THE PATIENT HAD THIS MEDICATION AT HOME. THE PATIENT WORE THE UNIT FOR A COUPLE OF HOURS TODAY. SHE HAD THE SAME PAIN BEFORE SHE STARTED WEARING THE BHS BUT NOT AS PAINFUL. THE PATIENT SPOKE TO THE DOCTOR ABOUT IT AND WAS

  Patient problems: Pain

  MAUDE report 12256619 ↗
• InjuryJan 4, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  FIRST ATTEMPT MADE BY EMAIL. AS PER CUSTOMER EXPERIENCE REP, (B)(6), IT WAS REPORTED BY THE SALES REP THAT THE PATIENT MENTIONED SWELLING OF THE ANKLE ON BOTH THE OUTER AND INNER AREAS. PATIENT STATED THAT THE SWELLING ON THE RIGHT FOOT STARTED LAST WEEK. THE PATIENT USED THE UNIT FOR 61 DAYS STRAIGHT THEN THE SWELLING STARTED. THE PATIENT STATED THAT THE SHE WOKE WITH SORENESS. THE PAIN LEVEL WAS AT A SEVEN. THE PAIN IS BELOW THE SKIN. SHARP SHOOTING PAINS. THE PAIN HAS NOT GONE AWAY. THE PAIN LEVEL IS THE SAME. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PATIENT SPOKE TO THE DOCTOR. THE PATIENT HAS AN APPOINTMENT ON (B)(6) 2020. THE PATIENT STATED THAT SHE IS NOT GOING TO USE THE STIMULATOR UNTIL SHE SPEAKS TO HER DOCTOR.

  Patient problems: Pain

  MAUDE report 11112581 ↗
• InjuryOct 30, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT'S HUSBAND STATED THAT SHE TOOK A SHOWER AND THE WATER TOUCHING HER FOOT FELT LIKE A BURNING SENSATION. THIS FOOT IS ALSO A DIFFERENT COLOR. THE BURNING SENSATION STARTED ON THE LEFT FOOT AND IT IS CONSTANT BUT IT INCREASES WHEN USING THE STIMULATOR. THE BURNING SENSATION IS BELOW THE SKIN AND IT IS PAINFUL. THE PAIN LEVEL IS AN EIGHT. THE PAIN LEVEL HAS REMAINED ABOUT THE SAME FOR 4 DAYS BUT IT INCREASES WHEN WEARING THE BHS UNIT. THE PATIENT IS NOT WEIGHT BEARING AT THIS TIME. THE PATIENT'S HUSBAND, RAYMOND STATED THAT THE LEFT FOOT IS PURPLE AND IT IS ALSO DARKER THAN THE RIGHT FOOT. I TOLD THE PATIENT'S HUSBAND TO STOP USING THE STIMULATOR AND TO CONTACT THE DOCTOR. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE SFXL COIL WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Burning Sensation; Pain

  MAUDE report 10762731 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS FROM USING THE SFLX 1 COIL. THE PATIENT IS USING THE SFLX 1 COIL ON HIS LEFT ANKLE. THE PATIENT STATED THAT HE CAN'T USE THE DEVICE BECAUSE HE HAS NERVE DAMAGE DOWN THE LEFT LEG AND TO THE TOP OF THE FOOT. THE SFLX 1 COIL IS CONSTANTLY RUBBING ON THE PATIENT'S SKIN WHICH MAKES IT FEEL LIKE A BAD SUNBURN. THE PATIENT DID CONTACT HIS DOCTOR AND THE DOCTOR PROVIDED A SCRIPT TO SWITCH THE PATIENT TO A DIFFERENT DEVICE FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9664236 ↗