Biomet SpinalPak / OrthoPakRecalls & reported problems across all models

We found 8 models of Biomet SpinalPak / OrthoPak by Ebi, LLC in the FDA's device registry (GUDID). Together they are named in 362 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Aug 12, 2026 — classified as 1 death, 359 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (309 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

Biomet SpinalPak / OrthoPak recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 22, 2024Open, Classified

   Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

   Z-1619-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 22, 2024Open, Classified

   Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

   Z-1618-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Biomet SpinalPak / OrthoPak problems

Biomet SpinalPak / OrthoPak models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Biomet SpinalPak / OrthoPak 106130-20

  Stimulator, Bone Growth, Non-Invasive
  1 death188 reports
• Biomet SpinalPak / OrthoPak 106130-22

  Stimulator, Bone Growth, Non-Invasive
  101 reports
• Biomet SpinalPak / OrthoPak 1067724-2

  Stimulator, Bone Growth, Non-Invasive
  1 recall4 reports
• Biomet SpinalPak / OrthoPak 106130-17

  Stimulator, Bone Growth, Non-Invasive
  52 reports
• Biomet SpinalPak / OrthoPak 1067724-4

  Stimulator, Bone Growth, Non-Invasive
  1 recall2 reports
• Biomet SpinalPak / OrthoPak 106130-12

  Stimulator, Bone Growth, Non-Invasive
  13 reports
• Biomet SpinalPak / OrthoPak 1067724-5

  Stimulator, Bone Growth, Non-Invasive
  1 report
• Biomet SpinalPak / OrthoPak 1067728-1

  Stimulator, Bone Growth, Non-Invasive
  1 report

Recent Biomet SpinalPak / OrthoPak adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Patient-Device Incompatibility

  It was reported that the patient experienced skin irritation with the 63B Electrodes. The patient stated that she thinks she let her skin heal prior to using the electrodes. The patient only wore the electrodes for a little while, not all day. The patient discontinued use of the bone growth stimulator due to the skin irritation issue and will be prescribed a different unit. No further consequences were reported.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50227787 ↗
• InjuryJun 16, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT REPORTED THAT THE 63B ELECTRODES CAUSED A RASH AND SEEMED TO BURN THE PATIENT¿S SKIN. THE PATIENT CLAIMED SHE COULD FEEL THE ELECTRIC CURRENT RUNNING THROUGH THE WIRES AND FELT A BURN LIKE FIRE ON HER NECK WHEN SHE TREATED. THE PATIENT ADVISED THAT SHE HAD SKIN ISSUES AND PAUSED TREATMENT FOR HER SKIN TO HEAL FROM TIME TO TIME. THE DERMATOLOGIST GAVE HER 2.5% HYDROCORTISONE CREAM TO HEAL THE SKIN BETWEEN TREATMENTS BUT ADVISED THE ISSUE WOULD NOT FULLY HEAL UNLESS SHE STOPPED TREATING. THE PATIENT ADVISED SHE NEVER PERFORMED A TIME TEST WHEN SWITCHING FROM ONE ELECTRODE TO THE NEXT. SHE TREATED 24 HOURS PER DAY, 7 DAYS PER WEEK UNTIL MARCH. THE PATIENT SAW THE SURGEON IN LATE MARCH, AND THE SURGEON RECOMMENDED TREATING AS MUCH AS THE PATIENT CAN TOLERATE. THE PATIENT SPOKE WITH THE PRESCRIBING DOCTOR AND A DERMATOLOGIST WHO SAID THAT NOT ONLY ARE THE 63B ELECTRODES CAUSING A SEVERE REACTION, BUT IT IS ALSO THE ELECTRICAL CURRENT THAT IS CAUSING HER SKIN TO BURN AND BECOME DISCOLORED AND EXTREMELY SORE. THE PATIENT¿S DOCTOR ULTIMATELY DECIDED TO PRESCRIBE AN ALTERNATIVE DEVICE DUE TO THE PATIENT¿S ONGOING SKIN IRRITATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Rash; Skin Discoloration

  MAUDE report 25517545 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED A BURNING PAIN IN HER BUTTOCKS AFTER SLEEPING WITH THE DEVICE LAST WEEKEND. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT THE PADS HAD BURNED HER ON HER BACK. THE PATIENT STATED SHE HAD PAIN IN HER BUTTOCKS. THE 72R ELECTRODES WERE CLOSE TO EACH OTHER, 3 INCHES APART. THE PATIENT STATED SHE HAS 2 RED MARKS ON HER BACK. SHE HAD THE ELECTRODES ON FOR 2 OR 3 DAYS WHEN SHE GOT THE BURN ON MAY 1ST. THE PATIENT STATED SHE HAS PAIN ON HER BUTTOCKS. THE PATIENT WENT TO HER PCP TODAY AND GOT AN INJECTION FOR THE PAIN. THE PATIENT STATED THE PAIN HAS GONE AWAY. THE PATIENT DID NOT CALL THE SURGEON. THE PATIENT HAS INCREASED HER DAILY ACTIVITIES. HER FOOT STARTED SWELLING. THE PAIN LEVEL FROM THE BURN WAS A 10. THE PATIENT ASKED HER HUSBAND TO TAKE THE ELECTRODES OFF. THE PAIN IN THE BUTTOCKS WAS A 10 AS WELL. THE PATIENT STATED THAT SHE DID NOT HAVE THIS PAIN BEFORE. THE PATIENT CANNOT SLEEP BECAUSE OF THE PAIN. THE PATIENT DOES NOT WANT TO CONTINUE TREATMENT. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Burn(s); Pain; Swelling/ Edema

  MAUDE report 25414862 ↗
• InjuryMay 11, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT STARTED HAVING SYSTEMIC ALLERGIC REACTIONS SINCE HER SURGERY. THE PATIENT WORE THE 72R ELECTRODES 24/7 AND CHANGED THEM EVERY NIGHT. THE PATIENT REPORTED BREAKING OUT IN LITTLE BUMPS WHICH WERE ALL OVER THE BODY. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN PREDNISONE AND TOPICAL CREAM. THIS DID NOT WORK. THE PATIENT ADVISED THAT THEY WOULD GO TO AN ALLERGIST SOON TO DETERMINE WHAT IS CAUSING THE ISSUE. THE PATIENT WAS SHIPPED ALTERNATE ELECTRODES TO TRY AND WILL CONDUCT A TIMED TEST. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 25142864 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO HAVE SKIN IRRITATION. THE PATIENT SPOKE WITH THE PRESCRIBING DOCTOR AND A DERMATOLOGIST WHO SAID THAT NOT ONLY ARE THE 72R ELECTRODES CAUSING A SEVERE REACTION, BUT IT IS ALSO THE ELECTRICAL CURRENT THAT IS CAUSING HER SKIN TO BURN AND BECOME DISCOLORED AND EXTREMELY SORE.THE PATIENT STATED THAT THE ELECTRODES CAUSED A RASH AND SEEMED TO BURN HER SKIN. THE PATIENT CLAIMED SHE COULD FEEL THE ELECTRIC CURRENT RUNNING THROUGH THE WIRES AND FELT A BURN LIKE FIRE ON HER NECK WHEN SHE TREATED. THE PATIENT ADVISED THAT SHE HAD SKIN ISSUES AND PAUSED TREATMENT FOR HER SKIN TO HEAL FROM TIME TO TIME. THE DERMATOLOGIST GAVE HER 2.5% HYDROCORTISONE CREAM TO HEAL THE SKIN BETWEEN TREATMENTS BUT ADVISED THE ISSUE WOULD NOT FULLY HEAL UNLESS SHE STOPPED TREATING. THE PATIENT ADVISED SHE NEVER PERFORMED A TIME TEST WHEN SWITCHING FROM ONE ELECTRODE TO THE NEXT. SHE TREATED 24 HOURS PER DAY, 7 DAYS PER WEEK UNTIL MARCH. THE PATIENT SAW THE SURGEON IN LATE MARCH, AND THE SURGEON RECOMMENDED TREATING AS MUCH AS THE PATIENT CAN TOLERATE. THE PATIENT¿S DOCTOR ULTIMATELY DECIDED TO PRESCRIBE AN ALTERNATIVE DEVICE DUE TO THE PATIENT¿S ONGOING SKIN IRRI

  Patient problems: Burn(s); Rash; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 24660835 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  THE PATIENT ADVISED THAT THE 72R ELECTRODES ARE CAUSING A SKIN IRRITATION IN THE CERVICAL AREA. THE SKIN IRRITATION STARTED A COUPLE OF MONTHS AGO. THE SKIN IS RED, ITCHY, CAUSING BLISTERS AND WELTS. THE ELECTRODES AND COVER PATCHES ARE CHANGED AND MOVED AROUND EVERY DAY. THE AREA IS CLEANED WITH SOAP AND WATER, NO WIPES. THE PATIENT IS USING OPZELURA CREAM PRESCRIBED BY HIS DERMATOLOGIST FOR THE IRRITATION IN THE CERVICAL AREA. THE PATIENT DID GO SEE THE DERMATOLOGIST FOR THIS ISSUE, THE SURGEON WAS NOT AWARE OF THE IRRITATION. THE PATIENT ADVISED THE SALES REP THAT 72R ELECTRODES ARE NOT STICKING AND CAUSING A MINOR IRRITATION, BUT NO ADVICE WAS GIVEN. THE PATIENT HAS NO KNOWN ALLERGIES, THE PATIENT HAS SEASONAL ALLERGIES. 63B ELECTRODES AND COVER PATCHES WERE SHIPPED TO THE PATIENT.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 24650165 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED SKIN IRRITATION WHEN USING THE COVER PATCHES. THE PATIENT INITIALLY HAD SKIN IRRITATION FROM THEIR DRESSING. THE COVER PATCHES WERE PLACED ON THE SAME AREA, ALSO CAUSING SKIN IRRITATION. THE PATIENT HAD WELTS AND BLISTERS. THE DOCTOR¿S OFFICE PUT THE PATIENT ON STEROIDS. THE PATIENT WAS ALSO APPLYING HYDROCORTISONE CREAM AND TAKING AN ANTIHISTAMINE. THE PATIENT HAS SENSITIVE SKIN AND IS ALLERGIC TO ADHESIVE, DERMABOND, AND PENICILLIN. THE PATIENT DISCONTINUED USE OF THE COVER PATCHES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 24649277 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION WITH THE 72R ELECTRODES. THE SKIN IRRITATION WAS ON THE LUMBAR AREA. THE PATIENT STATED THAT THE SKIN IS RED AROUND THE EDGE AND IT GETS ITCHY BY THE END OF THE DAY. THE PATIENT CHANGES THE ELECTRODES ONCE PER WEEK BUT REMOVES THEM EVERY NIGHT. THE ELECTRODES ARE NOT MOVED AROUND TO DIFFERENT LOCATIONS. THE IRRITATED AREA WAS CLEANED WITH AN ALCOHOL PAD. THE PATIENT APPLIED BENADRYL CREAM FOR THE ITCHING. THE PATIENT WAS SHIPPED ALTERNATE ELECTRODES TO TRY. IT WAS LATER REPORTED THAT THE PATIENT¿S DOCTOR ADVISED HER TO DISCONTINUE TREATMENT AT A FOLLOW UP APPOINTMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24332726 ↗
• InjuryJan 26, 2026Patient-Device Incompatibility

  IT WAS REPORTED BY THE SALES REPRESENTATIVE (B)(6) THAT THE PATIENT HAD A SKIN IRRITATION WITH 72R ELECTRODES. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT TO COLLECT DETAILS AND HAD TO LEAVE A VOICEMAIL FOR A RETURN CALL. THE PATIENT CALLED BACK AND ADVISED THE IRRITATION STARTED WEEKS AGO ON (B)(6) 2025. THE PATIENT SAW HER DOCTOR REGARDING THE IRRITATION AND THE DOCTOR TOLD HER TO REDUCE THE TIME TO 30 MINUTES AND THEN GRADUALLY INCREASE THE TIME. BY THIS TIME THE PATIENT HAS STOPPED USING THE SPAK AFTER FOLLOWING THE DOCTOR'S INSTRUCTIONS THE ITCHING AND REDNESS WAS TOO MUCH. AND SHE COULD NOT DO IT. THE PATIENT CLEANS THE AREA WITH ALCOHOL AND TRIED AGAIN. THE PATIENT STARTED ITCHING WITHIN AN HOUR. THE PATIENT HAS SENSITIVE SKIN. THE ELECTRODES WERE USED AT LEAST 3 OR 4 TIMES BEFORE CHANGING THEM. THE PATIENT REMOVED THE ELECTRODES WHEN SHE TOOK A SHOWER. THE SKIN WAS RED AND ITCHY. NO WELTS OR BLISTERS. THE AREA WAS CLEANED WITH SOAP AND WATER ONE DAY SHE USED ALCOHOL. THE PATIENT DID NOT APPLY ANYTHING ON THE AREA. THE PATIENT HAS FOOD ALLERGIES AND SEASONAL ALLERGIES. A PCP PRESCRIBED A CREAM. THE PATIENT WAS NOT HOME TO OFFER THE NAME OF THE CREAM. THE PATIENT W

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24183765 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  UPDATE ON 15DEC2025: SECOND ATTEMPT MADE BY PHONE FOR ADDITIONAL INFORMATION AND TO CONFIRM MEDICAL INTERVENTION. PATIENT ADVISED THAT SHE ALSO EXPERIENCED SKIN IRRITATION WITH THE 63B ELECTRODES. SHE ALLOWED THE IRRITATION WITH THE 72R ELECTRODES TO RESOLVE COMPLETELY BEFORE TRYING THE 63B ELECTRODES. SHE STARTED OFF WITH ONE HOUR AND WAS ABLE TO GET TO THREE HOURS OF TREATMENT BEFORE EXPERIENCING THE IRRITATION. THE AREA BECAME RAISED AND VERY ITCHY. PATIENT STATED THAT THE IRRITATION IS THE SAME AS WITH THE 72R ELECTRODES, SHE DID NOT NOTICE ONE BEING WORSE THAN THE OTHER. THE PATIENT HAS NOT DISCUSSED THE IRRITATION WITH THE 63B ELECTRODES WITH THEIR DOCTOR. PATIENT ADVISED THAT THE DOCTOR RECOMMENDED USING HYDROCORTISONE CREAM AND ANOTHER OINTMENT SHE COULD NOT RECALL FOR THE SKIN IRRITATION WITH THE 72R ELECTRODES. PSS BRIANNE MCGILL ADVISED THE PATIENT THAT WE DO NOT HAVE ANOTHER TYPE OF ELECTRODE. ADVISED THE PATIENT TO DISCUSS WITH SALES REP AND/OR DOCTOR FOR NEXT STEPS. PATIENT WILL RETURN A SAMPLE OF THE 72R ELECTRODES. PATIENT STATED THAT THE SKIN IRRITATION STARTED LAS WEEK ON THE CERVICAL AREA. THE SKIN IS VERY ITCHY WITH WELTS. THE DOCTOR'S OFFICE TOLD HER THIS MORNI

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 24003254 ↗
• InjuryJan 6, 2026Patient-Device Incompatibility

  DURING SUPPLY ORDER THE PATIENT MENTIONED THAT AT THE BEGINNING OF TREATMENT SHE TRIED THE COVER PATCHES ON ONE DAY ONLY. WHEN SHE REMOVED THE COVER PATCH FROM HER NECK THE ADHESIVE WAS VERY STICKY, SHE COULD NOT GET THE COVERS OFF SO SHE HAD TO RIP IT OFF QUICKLY LIKE A BAND-AIDE AND THIS WAS VERY PAINFUL AND LEFT A RED BRUISE ON HER SKIN. THE PATIENT ASSESSED THE PAIN AT AN 8 OUT OF 10 AND THE PAIN DID NOT LAST LONG. THE PATIENT DID NOT SPEAK TO HER DOCTOR ABOUT THIS EVENT. SHE CONTINUED TREATING WITHOUT THE COVER PATCHES AND EVERYTHING IS WORKING WELL WITHOUT THEM. THE PATIENT WILL RETURN ONE UNUSED COVER PATCH WITH THE POUCH PROVIDED. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

  Patient problems: Bruise/Contusion; Erythema; Pain

  MAUDE report 23983554 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SALES REP ADVISED THAT THE 63B ELECTRODES IRRITATED THE PATIENT. THE PATIENT WAS CALLED AND ADVISED THAT THE 63B ELECTRODES IRRITATED HIS SKIN. THE SKIN WAS RED, ITCHY, AND HAS WELTS. HE CALLED HIS DOCTOR'S NURSE AND THEY TOLD HIM TO CALL HIS SALES REP AND USE HYDROCORTISONE IF NEEDED AND THIS DID NOT HELP. THE PATIENT USED NOTHING ON HIS SKIN SO IT WOULD DRY OUT. THE PATIENT HAS SENSITIVE SKIN AND AN ALLERGY TO LATEX. 72R ELECTRODES WERE SHIPPED TO THE PATIENT. RETURN NOTED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Inflammation/ Irritation

  MAUDE report 23623893 ↗
• InjuryNov 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS DISCONTINUING USE OF THE ORTHOPAK AND SWITCHING TO THE BONE HEALING SYSTEM (BHS) DUE TO SKIN IRRITATION WITH THE ELECTRODES. THE PATIENT WORE THE 72R ELECTRODES FOR 10 TO 15 HOURS PER DAY. THE ELECTRODES WERE CHANGED DAILY, AND THE PATIENT ALSO WORE THE COVER PATCHES. THE RASH WAS ALL OVER THE PATIENT¿S BODY. THE PATIENT TOOK BENADRYL IN ADDITION TO MEDICATION FOR DIABETES AND HIGH BLOOD PRESSURE. THE PATIENT ADVISED THEIR DOCTOR OF THE SKIN IRRITATION AT A FOLLOW-UP VISIT AND THE DOCTOR RECOMMENDED SWITCHING TO THE BHS. NO FURTHER CONSEQUENCES ARE REPORTED. THE PRODUCT WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 23568814 ↗
• InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORTED GETTING ELECTRIC SHOCKS FROM THE UNIT. THE PATIENT USED THE UNITS 3 TIMES. THE PATIENT STATED THAT WHEN SHE TOOK OFF THE UNIT, SHE FELT ELECTRIC SHOCKS AFTER WEARING IT FOR 4 HOURS. PATIENT STATED THE PAIN LEVEL WAS 15 OUT OF 10. ON THE FIRST DAY THE PATIENT HAD HEADACHES AND NAUSEA AFTER USING THE UNIT FOR ONE HOUR. ON THE THIRD DAY THE PATIENT WORE THE UNIT FOR ABOUT 8 HOURS. THE PATIENT STATED THAT SHE HAS NOT EXPERIENCED ANY FEELINGS LIKE THAT SINCE SHE STOPPED USING THE UNIT. A REPLACEMENT CONTROLLER AND ELECTRODES WERE SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE PRODUCT WAS RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23391515 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE 72R ELECTRODES CAUSED A SKIN IRRITATION. IT WAS A RASH THAT WAS RED WITH BLISTERS AND WAS VERY ITCHY. THE PATIENT USED BENADRYL AND HYDROCORTISONE CREAM TO APPLY OVER THE AFFECTED AREA. THE PATIENT WAS NOT SURE IF THIS HAD BEEN PRESCRIBED PREVIOUSLY. THE PATIENT STATED HE IS NOT SURE IF HIS WIFE CONTACTED THE DOCTOR REGARDING THE SKIN IRRITATION. THE PATIENT WILL START USING THE 63B ELECTRODES ONCE THEIR SKIN HAS HEALED FROM THE RASH. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Blister; Rash; Skin Inflammation/ Irritation

  MAUDE report 23351924 ↗

Other Ebi, LLC products

• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2 models · 284 reports · 1 recall
• Biomet EBI Bone Healing System12 models · 327 reports
• Biomet OrthoPak Non-invasive Bone Growth Stimulator System2 models · 42 reports · 1 recall