Biomet OrthoPak Non-invasive Bone Growth Stimulator SystemRecalls & reported problems across all models

We found 2 models of Biomet OrthoPak Non-invasive Bone Growth Stimulator System by Ebi, LLC in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2019 and Jun 16, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (24 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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 OrthoPak Non-invasive Bone Growth Stimulator System 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, 2024Class IIOpen, 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-1617-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Biomet OrthoPak Non-invasive Bone Growth Stimulator System problems

Biomet OrthoPak Non-invasive Bone Growth Stimulator System models

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

• Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718

  Stimulator, Bone Growth, Non-Invasive
  1 recall41 reports
• Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067719

  Stimulator, Bone Growth, Non-Invasive
  1 report

Recent Biomet OrthoPak Non-invasive Bone Growth Stimulator System adverse event reports

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

• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DISCOMFORT DURING TREATMENT WITH THE DEVICE. THE PATIENT STATED THAT TOWARDS THE END OF THE NIGHT, THE LEFT ANKLE HURTS. THE PATIENT MANAGES THE PAIN BY TREATING WITH THE DEVICE EVERY OTHER DAY. THE PATIENT SPOKE WITH HER DOCTOR WHO SAID IT WAS OKAY TO TREAT EVERY OTHER DAY; HER DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT STATES THAT WHEN SHE USES THE UNIT, SHE EXPERIENCES PAIN, AND THE PAIN LEVEL IS A 4. IF THE PATIENT USES THE UNIT FOR TWO DAYS IN A ROW, THE PAIN LEVEL IS AT A 10. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25520272 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REP ADVISED THAT THE PATIENT'S ANKLE HAS BEEN IN A LOT OF PAIN SINCE WEARING THE UNIT. THE PATIENT WAS CALLED AND ADVISED THAT SHE USED THE UNIT FOR 24 HOURS AND WAS IN MORE PAIN AFTER USING THE UNIT. THE PATIENT WAS IN PAIN BEFORE USING THE UNIT. THE PATIENT STOPPED USING THE UNIT AND CALLED THE DOCTOR, SHE'S WAITING FOR A CALL BACK. THE PATIENT WAS ADVISED TO TAKE A TIME TEST. NO RETURN NOTED. UPDATE 12/15/25: THE PATIENT WAS CALLED AND HER PAIN LEVEL WAS A 10.

  Patient problems: Pain

  MAUDE report 23982516 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING STABBING, SHARP PAIN WHEN SHE TREATS WITH THE ORTHOPAK.THE PATIENT WAS ADVISED TO REMOVE THE ELECTRODES AND ONLY USE THE UNIT FROM 30 MINUTES TO 2 HOURS. THE DOCTOR SUBMITTED A NEW RX FOR THE PATIENT TO SWITCH TO A BHS DEVICE TO SEE IF THE PATIENT CAN TOLERATE THIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 23597308 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DURING TREATMENT WITH THE ORTHOPAK. THE PATIENT WAS SWITCHED TO THE BONE HEALING SYSTEM (BHS). IT WAS LATER REPORTED THAT THE PATIENT ATTEMPTED TO USE THE ORTHOPAK FOR ABOUT A WEEK. NO FURTHER INFORMATION COULD BE PROVIDED REGARDING HOW LONG THE PATIENT WAS ABLE TO TREAT WITH THE DEVICE BEFORE THE PAIN STARTED. NO FURTHER CONSEQUENCES ARE REPORTED. THE ORTHOPAK WAS RECEIVED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23568616 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY EXPERIENCED SHOOTING PAINS WHILE TREATING WITH THE BONE STIMULATOR. PATIENT STATED HE WAS TREATING HIS RIGHT BIG TOE WHEN HE WAS SLEEPING AND THEN ONCE WHEN HE WAS AWAKE. BOTH TIMES HE EXPERIENCED SHARP SHOOTING PAINS ON THE OUTSIDE OF HIS RIGHT THIGH EVERY COUPLE OF SECONDS. THE PAIN WAS CONSTANT UNTIL HE STOPPED TREATMENT. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 23404232 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING THROBBING PAIN WHILE USING THE ORTHOPAK DEVICE. THE PATIENT HAD BEEN WEARING THE DEVICE 24 HOURS PER DAY SINCE (B)(6) 2025 AND THE PAIN STARTED ON (B)(6) 2025. THE PATIENT DID NOT DO ANY EXTRA ACTIVITIES. THE PATIENT RATED THE PAIN AS AN 8 OR 9 ON A SCALE OF 1-10. THE PATIENT IS TAKING TYLENOL AND AWAITING A CALL BACK FROM THEIR DOCTOR. CUSTOMER SERVICE ADVISED THE PATIENT TO REMOVE THE DEVICE FOR A FEW DAYS. IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO TREAT FOR 8 TO 10 HOURS PER DAY AND HER PAIN LEVEL REMAINED AT AN 8 OR 9 OUT OF 10. THE PATIENT IS UNABLE TO PINPOINT WHEN THE PAIN STARTS SINCE IT COMES AND GOES. THE PAIN IS IN THE LEFT SHOULDER WHERE THE FRACTURE IS. THE PATIENT STATED THAT SHE HAS A FOLLOW UP APPOINTMENT WITH HER ORTHOPEDIC DOCTOR ON (B)(6) 2025. THE PATIENT WANTS TO CONTINUE TREATING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21677161 ↗
• InjuryDec 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHILE USING THE ORTHOPAK. IT WAS LATER REPORTED THAT THE PATIENT HAS PAIN WHILE WALKING. EVERY TIME THE PATIENT MOVES HIS ARM IT HURTS. THE PAIN STARTED AFTER USING THE ORTHOPAK. THE PAIN IS AT THE FRACTURE SITE AND THE PATIENT RATED THE PAIN A 10 OUT OF 10. THE PATIENT DID NOT SPEAK TO HIS DOCTOR. THE PATIENT IS TAKING IBUPROFEN 600 MILLIGRAMS BUT IT DOES NOT HELP. THE PATIENT STOPPED USING THE DEVICE (B)(6) 2024, BUT THE PAIN DID NOT SUBSIDE AT ALL. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO CONTACT THE DOCTOR AND TO TAKE A BREAK FROM TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20989486 ↗
• InjuryNov 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 THAT THE PATIENT HAD NAUSEA, HEADACHES, AND BODY TINGLING. THE PATIENT SPOKE WITH THEIR ORTHOPEDIC SURGEON WHO REPORTEDLY STATED THAT HE HAD HEARD OF PATIENTS HAVING THESE SYMPTOMS. THE PATIENT WAS ADVISED BY HER PHYSICIAN TO DISCONTINUE USE AS THERE WAS NO BONE GROWTH AFTER USING THE STIMULATOR FOR 2 MONTHS. THE PATIENT WAS USING THE DEVICE ON HER LEFT FOOT. NO ADDITIONAL PATIENT CONSEQUENCES/ FURTHER INFORMATION HAS BEEN REPORTED. THE ORTHOPAK ASSEMBLY WAS NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Headache; Nausea; Paresthesia

  MAUDE report 20657251 ↗
• InjurySep 16, 2024Adverse 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 SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN WHILE USING ORTHOPAK UNIT. LATER, THE PATIENT WAS CONTACTED AGAIN FOR ADDITIONAL INFORMATION AND STATED THAT THEY HAVE BEEN WEARING THE DEVICE FOR TOO LONG AND INDICATED THAT THE PAIN WAS AT 10 ON A SCALE OF 1-10. THE PATIENT CONTACTED THEIR PHYSICIAN BUT, THE CAUSE OF THE PAIN WAS NOT IDENTIFIED, AND DOCTOR DID NOT PRESCRIBE ANY MEDICATIONS. THE PATIENT DECIDED TO CONDUCT A TIME-TEST AS ADVISED BY THE SALES REPRESENTATIVE AND STATED THAT THE PAIN SUBSIDED WITH SHORTER TREATMENT TIME. NO FURTHER INFORMATION HAS BEEN REPORTED. THE ORTHOPAK UNIT HAS NOT BEEN RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 20224390 ↗
• InjuryMay 24, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED A CRAMP IN HER FOOT WHILE TREATING WITH THE ORTHOPAK DEVICE. THE PATIENT IS TREATING HER BIG TOE. THE PATIENT RATED THE PAIN LEVEL AN 8 OUT OF 10, 10 BEING THE HIGHEST. USUALLY WHEN SHE TURNS THE DEVICE OFF THE CRAMPS DISAPPEAR. THE PATIENT STATED THAT THIS DISCOMFORT BEGAN ABOUT ONE WEEK AFTER SHE STARTED TREATING. AND HAS BEEN HAPPENING FOR ABOUT ONE MONTH OF TREATMENTS. THE PATIENT SPOKE WITH HER FOOT DOCTOR, WHO SUGGESTED THAT SHE CONTACT US AND HAD NO OTHER ADVICE. THE PATIENT STATED THAT SHE EXPERIENCED PAIN FROM HER FOOT TO THE CALF WHILE DRIVING AND WAS NOT TREATING WITH THE DEVICE. THE LAST TIME SHE TREATED BEFORE TODAY'S DISCOMFORT WAS YESTERDAY BEFORE BEDTIME. THE PATIENT WAS ADVISED TO PAUSE TREATMENT UNTIL SHE HAD NO DISCOMFORT. SHE CAN PERFORM THE TIME TEST AND BEGIN THE TEST AT 30 MINUTES PER DAY FOR THREE DAYS IF SHE IS COMFORTABLE, THEN ADD 30 MINUTES EVERY 3 DAYS. THE PATIENT AGREED TO CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19397908 ↗
• InjuryMay 1, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS HAVING HEADACHES WHEN USING ORTHO PAK., NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF TODAY.

  Patient problems: Headache

  MAUDE report 19222580 ↗
• InjuryDec 12, 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 THAT THE PATIENT HAS EXPERIENCED 2 MIGRAINES SINCE HE STARTED USING THE ORTHO PAK DEVICE THE PATIENT IS USING THE ORTHOPAK ON HIS FOOT BUT WAS WONDERING IF THE STIMULATOR COULD BE TO BLAME. THE PATIENT STOPPED USING THE STIMULATOR ON SATURDAY. THE PATIENT ALSO MENTIONED THAT HE HAS COMPLEX REGIONAL PAIN SYNDROME. THE PATIENT SPOKE WITH HIS DOCTOR AND THE DOCTOR CALLED THE ZIMVIE SALES REPRESENTATIVE. THE PATIENT IS TAKING IBUPROFEN/TYLENOL FOR PAIN. THE PATIENT WAS ADVISED TO CONDUCT A TIME TEST AT ONE-HOUR INCREMENTS AFTER THE PAIN SUBSIDES. THE PATIENT WILL CALL BACK WITH AN UPDATE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Headache; Pain

  MAUDE report 18310144 ↗
• InjuryNov 29, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT REPORT THAT HE FELT A BURNING SENSATION ON HIS SKIN WHILE TREATING WITH THE ORTHOPAK DEVICE. THE PATIENT STATED THAT HE FOUND A HUGE BURN ON THE SKIN. THE PATIENT SPOKE TO HIS FOOT DOCTOR AND PRIMARY CARE PHYSICIAN. THE PRIMARY CARE PHYSICIAN ADVISED THE PATIENT TO USE AN ANTIBIOTIC OINTMENT. THE PATIENT STATED THAT HE CONTACTED THE ZIMVIE SALES REPRESENTATIVE WHO ADVISED HIM TO USE THE 48" LEAD WIRE AND TO KEEP THE CONTROLLER IN HIS PANTS POCKET INSTEAD OF THE SOCK. THE PATIENT'S SKIN WAS RED, SWOLLEN AND IT HAD A BLISTER. THE SKIN ISSUE WAS THE SHAPE OF THE CONTROLLER FROM WEARING IT AGAINST HIS SKIN. THE PATIENT¿S ATTORNEY IS IN POSSESSION OF THE DEVICE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 18231968 ↗
• InjuryNov 29, 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 HE HAS A METAL ROD IN THE FEMUR. THE PAIN INCREASES WHEN HE USED THE DEVICE, THEN DECREASES WHEN HE STOPS TREATING WITH THE DEVICE. THE PATIENT CONTACTED THE DOCTOR¿S OFFICE AND LEFT A MESSAGE WITH ASSISTANT. THE PATIENT DID NOT SPEAK TO THE DOCTOR ONLY WITH THE ZIMVIE SALES REPRESENTATIVE. THE PATIENT WORE THE DEVICE 24/7. THE PATIENT WILL STOP WEARING THE DEVICE AND CONDUCT TIMED TEST. HE WILL CALL BACK IF ANY ISSUES. THE PATIENT LATER REPORTED THAT THE PAIN IS BELOW THE SKIN. THE PATIENT RATED THE PAIN LEVEL AS AN 8 ON A SCALE FROM 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT HAS NOT BEEN ABLE TO GET IN TOUCH WITH HIS DOCTOR BUT DOES HAVE AN APPOINTMENT ON DECEMBER 20TH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Limb Pain; Pain

  MAUDE report 18231434 ↗
• InjuryAug 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH THE ORTHO PAK DEVICE. THE PATIENT DOES NOT FEEL PAIN WHILE USING THE STIMULATOR. THE PATIENT FEELS A LITTLE MORE PAIN THAN USUAL THE DAY AFTER THE TREATMENT, BUT SHE IS NOT SURE WHETHER THE PAIN IS FROM THE UNIT OR FROM PHYSICAL THERAPY. THE LAST X-RAY THAT WAS TAKEN LAST WEEK HAD SHOWN BONE HEALING. THE PAIN IS BELOW THE SKIN. THE PATIENT TOLD HER THE DOCTOR ABOUT THE PAIN AND WAS ADVISED TO CONTINUE USING THE DEVICE. THE PATIENT STATED THAT HER RIGHT ARM IS BROKEN, AND SHE IS HAVING A HARD TIME PUTTING THE UNIT ON. THE PATIENT RATED THE PAIN AS A 4 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT HAS INCREASED HER DAILY ACTIVITY. THE PATIENT IS HAVING PHYSICAL THERAPY. THE DOCTOR IS HAPPY THAT SHE HAS THE DEVICE. THE DOCTOR PRESCRIBED HYDROCODONE WITH ACETAMINOPHEN. THE PATIENT SOMETIMES TAKES THE PRESCRIBED MEDICATION OR WILL TAKE TYLENOL OVER THE COUNTER. THE PATIENT MENTIONED SHE HAD A SKIN RASH FOR ABOUT A WEEK BUT THEN IT WENT AWAY. HOWEVER, THE PATIENT DID NOT WANT TO SPEAK ABOUT THE RASH. THE PATIENT WAS NOT SENT A REPLACEMENT PRODUCT. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 17652190 ↗

Other Ebi, LLC products

• Biomet SpinalPak / OrthoPak8 models · 362 reports · 2 recalls
• Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2 models · 284 reports · 1 recall
• Biomet EBI Bone Healing System12 models · 327 reports