TMJ SYSTEM 24-6564Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036036607), received between Oct 16, 2020 and Oct 16, 2020 — classified as 1 injury.

17 other recalls cover devices cleared under the same FDA submission (P020016); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THREE (3) YEARS AGO. IMMEDIATELY FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED BELL¿S PALSY ON THE RIGHT SIDE AND WAS INFORMED BY THE SURGEON THAT IT WAS A POSSIBLE REACTION TO THE SURGERY. THE PATIENT HAS USED A BITE SPLINT FOR THREE (3) YEARS TO ALIGN THE BITE. THE PATIENT HAD A ROOT CANAL A COUPLE MONTHS AGO AND THE ENDODONTIST TOOK CONE BEAM IMAGING. BASED ON THE IMAGING, THE ENDODONTIST BELIEVES THE DEVICE IS RUBBING THE BONE AND THAT THE SPLINT INCREASES THE PAIN. THE PATIENT HAS AN UNSPECIFIED ONE (1) INCH DEFORMITY IN THE JAW. THE PATIENT UNDERWENT A DRY NEEDLING TREATMENT ONE (1) YEAR AGO THAT DID NOT PROVIDE ADEQUATE PAIN RELIEF. THE PATIENT WISHES TO GET A REFERRAL TO A NEUROLOGIST TO SEE IF A SCREW IS POTENTIALLY HITTING A NERVE. THE PATIENT IS CURRENTLY RECEIVING BOTOX SHOTS IN THE JAW FROM THEIR DENTIST IN ORDER TO TRY TO RELAX THE MUSCLES. THE PATIENT IS NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. THE PATIENT HAS BEEN TOLD BY AN ORAL SURGEON THAT THE PATIENT HAS EXPERIENCED TOO MUCH BONE LOSS TO UNDERGO ADDITIONA

  Patient problems: Facial Nerve Paralysis; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10689171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020016. One submission often covers many models, so check the product and lot details in each record.

• Z-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0522-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
• Z-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
• Z-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0510-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0515-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0518-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
• Z-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-2566-2014 · Sep 20, 2013 · Terminated
  Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to

…and 2 more.