Biomet EBI Bone Healing System 1068224Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812301020492), received between Oct 26, 2021 and Feb 16, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 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 THAT. THE PATIENT STATED THAT THE DEVICE IS CUMBERSOME. THE SFLX COIL 5 IS TOO BIG AND THE SFLX COIL 4 IS TOO SMALL. THE DEVICE IS KEEPING HER UP AT NIGHT. THE PATIENT STATED THAT HER LEG HURTS WHILE SHE WAS TREATING, BUT NOT ALL THE TIME. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PAIN IS BELOW THE SKIN'S SURFACE. THE PATIENT DID NOT SPEAK TO HER DOCTOR. THE PATIENT DOES NOT WANT TO HAVE SURGERY AGAIN. THE PAIN LEVEL IS A 4. THE PATIENT HAS AN APPOINTMENT WITH HER DOCTOR AT THE END OF MARCH. AN EXTRA VELCRO WAS SENT TO TRY TO KEEP THE COIL IN PLACE. IT WAS LATER REPORTED THAT THE PATIENT WAS SWITCHED FROM THE BHS ASSEMBLY TO THE ORTHOPAK ASSEMBLY BY HER PHYSICIAN. THIS IS CONSIDERED MEDICAL INTERVENTION AND THIS COMPLAINT IS CONSIDERED REPORTABLE. THE PATIENT LATER REPORTED THAT SHE HAD PAIN WITH THE SFLX 5 COIL.

  Patient problems: Pain

  MAUDE report 18720711 ↗
• InjuryDec 15, 2022Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  UNIT GETS VERY HOT AND IS UNCOMFORTABLE TO USE AS PER CS REP ANA MARIA LEPIANA, IT WAS REPORTED BY THE SALES REP THAT THE PATIENT FINDS THE BHS UNIT UNCOMFORTABLE AND THE UNIT GETS VERY HOT. SALES REP REQUESTED TO SWITCH TO AN OPAK, HE WAS ADVISED TO FORWARD A NEW RX AND DR NOT EXPLAINING WHY THERE SHOULD BE A SWITCH. (B)(6) RECEIVED THE SIGNED AND DATED RX AND NOTE FROM THE DOCTOR., SALES REP WAS ADVISED HE CAN APPLY THE OPAK FROM HIS TRUNK STOCK AND TO PICK UP THE COMPLETE BHS UNIT INCLUDING THE COILS FROM THE PATIENT. A RETURN LABEL WAS SENT TO THE SALES REP.

  Patient problems: Burning Sensation; Discomfort

  MAUDE report 15991872 ↗
• InjuryOct 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT COMPLAINED ABOUT THE UNIT ONLY LASTING A FEW HOURS WHEN FULLY CHARGED. HE VERY SELDOM USES THE UNIT, AND IT CAUSES PAIN. THE PATIENT ALSO COMPLAINED THAT THE COIL WAS TOO BIG.

  Patient problems: Pain

  MAUDE report 12697612 ↗