Biomet EBI Bone Healing System 1068235Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00812301020577), received between Jul 24, 2020 and Nov 17, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING IRRITATION WITH THE COIL, THE PATIENT STATED IT IS ON THE LATERAL SIDE OF HER KNEE. PATIENT SAID THE COIL IS NOT TIGHT, IT IS A RAISED AREA. SHE WORE THE UNIT FOR 2 MONTHS STATED IT STARTED ABOUT A WEEK - 2 WEEKS AGO. PATIENT IS ACTIVE BUT NOT WITH THE UNIT. THE PATIENT USES A WALKER AND SHE TREATS AT NIGHT. THE PATIENT WAS ADVISED TO STOP WEARING THE UNIT AND CALL THE DOCTOR. PATIENT WILL CALL BACK WITH AN UPDATE. CS SPOKE WITH THE PATIENT AND SHE STATED IT IS NOT FROM THE COIL RUBBING ON HER SKIN. SALES REP STATED THAT THE DOCTOR WAS THE ONE TO CALL THEM AND REQUESTED A SWITCH TO AN OPAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23569464 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER SALES REP EMAIL PATIENT CLAIMING HE HAD BLISTER AND PAIN WHEN HE USED THE STIMULATOR IN SEPTEMBER. HE STOPPED BUT THE SURGEON WANTS HIM TO START USING IT AGAIN. CALLED THE PATIENT COULD NOT LEAVE A MESSAGE THE MAILBOX WAS FULL.

  Patient problems: Pain

  MAUDE report 23373091 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT IT WAS PAINFUL TO USE THE DEVICE FOR MORE THAN 45 MINUTES STRAIGHT. THE PATIENT STATED IT FELT PAINFUL, AS IF THEIR FOOT WAS BEING SQUEEZED AND THE METALS THAT WERE PLACED INSIDE WERE BEING PULLED OUT. THE PATIENT MENTIONED IT TO THEIR DOCTOR AND WAS ADVISED TO CONTACT THE SALES REPRESENTATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 23051574 ↗
• InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCRUCIATING PAIN AFTER 2 HOURS OF TREATMENT. THE PATIENT STATED THAT SHE IS FINE ALL DAY WITH NO PAIN BUT AFTER ABOUT 1 HOUR OF TREATMENT THE PAIN STARTS. THE PATIENT STATED THAT LAST NIGHT THE PAIN GOT SO BAD SHE HAD TO TAKE AN OXYCODONE. THE PATIENT HAS NOT DISCUSSED THE ISSUE WITH HER DOCTOR. THE PATIENT STATED SHE HAS NEVER SPOKEN WITH A SALES REPRESENTATIVE. PRODUCT SURVEILLANCE SPECIALIST (B)(6) GAVE THE PATIENT THE PHONE NUMBER FOR (B)(6) WHO IS LISTED AS THE SALES REPRESENTATIVE IN FILENET AND ADVISED THE PATIENT TO CONTACT THE SALES REP WITH THE CONCERN. NOTE: THIS INFORMATION WAS OBTAINED DURING SECOND ATTEMPT CALL FOR (B)(4). UPDATE 8/12: PER SECOND ATTEMPT CALL, THE PATIENT STATED THAT SHE HAD TO STOP USING THE UNIT DUE TO THE PAIN. THE PATIENT STATED THAT THE PAIN WAS EXCRUCIATING, RATED THE PAIN AN 8 OR 9 OUT OF 10. THE PATIENT REACHED OUT TO HER DOCTOR TO DISCUSS GETTING MORE PAIN MEDICATION BUT HER DOCTOR ADVISED HER TO STOP USING THE UNIT INSTEAD. THE PATIENT WAS ASKED IF SHE WOULD LIKE TO RETURN THE DEVICE FOR EVALUATION AND STATED SHE WOULD HAVE TO DISCUSS WITH HER DOCTOR, THE PATIENT MAY WANT TO RESUME TREATMENT AT S

  Patient problems: Pain

  MAUDE report 22926861 ↗
• InjuryDec 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT IS HAVING TROUBLE WITH HER BHS UNIT. THE PATIENT WAS CALLED TO TROUBLESHOOT THE UNIT. THE PATIENT STATED THAT SHE FEELS THE TOP OF HER TOES STINGS AND FEELS LIKE A BURNING SENSATION WHICH HURTS BAD AFTER USING THE UNIT. THE PATIENT SAW HER DOCTOR YESTERDAY. THE PATIENT'S FOOT IS VERY SWOLLEN BECAUSE OF THE SURGERY. THE FOOT IS SENSITIVE. SHE HAD THE SURGERY 9 DAYS AGO. THE PATIENT IS USING SFLX 4 COIL. THE PATIENT STATED THAT HER SPLINT WAS CHANGED, AND IT IS NOT AS BULKY. THE COIL 4 IS NOW A LITTLE BIT TOO BIG. LATER, THE PATIENT STATED THAT THE PAIN IS LIKE A BURNING SENSATION IN HER NERVES AND THAT SHE BELIEVES THE BHS IS INCREASING HER PAIN. THE PATIENT SPOKE TO HER DOCTOR AND WAS TOLD TO CALL ZIMVIE. THE DOCTOR ALSO PRESCRIBED GABAPENTIN FOR NERVE PAIN. THE PATIENT ALSO STATED THAT THE PAIN WAS AN 8 OR 9 WHEN STATIONERY AND WAS A TEN OUT OF TEN WHEN SHE IS MOVING AROUND. THE PATIENT IS NOT TREATING WITH THE UNIT AT THIS TIME AND HER DOCTOR HAS BEEN MADE AWARE OF THIS. THE PATIENT DECIDED TO STOP TREATMENT ON HER OWN DUE TO THE PAIN. SHE WILL RESUME TREATING WHEN SHE RECEIVES THE NEW COIL. NO ADDITIONAL PATIENT CONSEQ

  Patient problems: Pain; Paresthesia; Skin Inflammation/ Irritation

  MAUDE report 18291615 ↗
• InjuryMay 17, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT WAS HAVING PAIN WHILE TREATING WITH THE BHS UNIT. THE CUSTOMER SERVICE REPRESENTATIVE SPOKE WITH PATIENT AND THE PATIENT STATED THAT SHE WAS HAVING PAIN IS IN THE LEFT LEG. IT WAS WHERE THE ROD AND PIN MEET. THE PAIN WAS WHEN SHE USES THE STIMULATOR AND WHEN IT IS OFF. THE PATIENT WILL BE SEEING HER DOCTOR ON FRIDAY AND WILL CALL US BACK. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE SFLX-4 COIL WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 16949914 ↗
• InjuryMay 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE, THAT THE PATIENT HAS MS AND FLARES UP WHILE USING HER BHS UNIT. THE PATIENT'S DOCTOR WAS CONTACTED ABOUT THIS ISSUE AND THE DOCTOR CHOSE TO SWITCH THE PATIENT TO AN ORTHOPAK UNIT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE SFXL COIL WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 16911121 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT IS COMPLAINING ABOUT THE BHS UNIT AND WOULD LIKE TO SWITCH THE PATIENT TO AN ORTHO PAK. THE PATIENT STATED SHE CANNOT WEAR THE UNIT AS THE COIL IS FALLING OFF HER FOOT. THE PATIENT WAS PLACING THE COIL UNDERNEATH HER SOCK, WHICH WAS "HURTING HER BUNION." THE PATIENT IS TREATING THE 5TH MET. THE PATIENT DID NOT CONTACT THE DOCTOR. THE PATIENT WILL BE SWITCHED TO AN OPAK, AND THE BHS ASSEMBLY AND COILS WILL BE RETURNED. A RETURN LABEL HAS BEEN SENT TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 15718033 ↗
• InjuryAug 10, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT UNDERWENT ORIF AND BONE GRAFT SURGERY TO REPAIR A DISTAL FIBULA NONUNION FRACTURE. AFTER SURGERY SHE BEGAN TO TREAT WITH A BHS UNIT SINCE SHE WAS IN A CAST FOR 6 WEEKS AND THE DOCTOR WANTED HER ON STIMULATOR IMMEDIATELY POST-OP. THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH THE DOCTOR. SHE STILL HAS NOT HEALED. THE DOCTOR WANTS HER TO CONTINUE WITH A BONE STIMULATOR BUT WANTS HER TO SWITCH TO ORTHOPAK BECAUSE THE PATIENT IS UNABLE TO TOLERATE THE BHS FOR MANY HOURS. THE PATIENT CLAIMS THAT SHE COULD ONLY USE BHS FOR 5-7 HOURS AT A TIME THEN HER FOOT WOULD FEEL VERY HOT LIKE HER "BONE WAS COOKING". SHE WOULD TAKE A BREAK AND CONTINUE A COUPLE OF HOURS LATER. THE DISCOMFORT WAS BURNING AND NOT PAINFUL, BUT IF SHE HAD TO ASSIGN A PAIN SCALE IT WOULD BE A 4 OR 5 UNDER THE SKIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation

  MAUDE report 15205157 ↗
• InjuryNov 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT STATED THAT THE ORIGINAL VELCRO DIDN'T STICK, PLUS THE PAIN FROM USING IT PREVENTED ME FROM DOING ANY ADLS, DRIVING OR PHYSICAL THERAPY AS IT KEPT ME TOO PAINFUL TO DO ANYTHING INCLUDING DRIVE DOWN THE STREET TO PHYSICAL THERAPY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE SFLX-4 COIL WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 12832434 ↗
• InjuryJul 24, 2020Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT WAS EXPERIENCING PAIN, SHOCK SENSATIONS, AND A BURNING SENSATION FROM USING THE BONE HEALING SYSTEM (BHS). THE PATIENT IS USING THE DEVICE ON HIS LEFT ANKLE. THE PATIENT REPORTED THAT THE SFLX 4 COIL IS GIVING HIM A BURNING SENSATION. THE PATIENT REPORTED THAT THE BHS AND COIL ARE GETTING VERY HOT. THE PATIENT FEELS A SHOCKING SENSATION ON THE SKIN FROM THE COIL. THE PATIENT RATED THE PAIN AS A 5, ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT REPORTED THAT HE HAS STEPPED ON THE COIL SEVERAL TIMES. THE PATIENT HAS RECENTLY INCREASED HIS DAILY ACTIVITIES. THE PATIENT REPORTED THAT HE RECENTLY HAD ANOTHER SURGERY. THE PATIENT REACHED OUT TO HIS DOCTOR WHO CALLED THE SALES REPRESENTATIVE. THE SALES REPRESENTATIVE ADVISED THE PATIENT TO CALL ZIMMER BIOMET. THE PATIENT STOPPED WEARING THE DEVICE FOR FIVE DAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 10319721 ↗