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TMJ SYSTEM 24-6650Recalls & reported problems

Biomet Microfixation, Inc · 50 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036063580), 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Extraskeletal ossification1
  • Loss of Range of Motion1

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 WILL UNDERGO A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THIRTEEN (13) YEARS FOLLOWING IMPLANTATION DUE TO HETEROTOPIC BONE GROWTH. THE PATIENT FEELS THAT THE DEVICES HAVE WORKED WELL AND IT IS THE BONY OVERGROWTH THAT CAUSES A LIMITED RANGE OF MOTION. IT IS POSSIBLE THE IMPLANTS WILL BE REPLACED WITH A CUSTOM DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Patient problems: Extraskeletal ossification; Loss of Range of Motion

    MAUDE report 10691222 ↗

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-0512-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off 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-0517-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
  • Z-0510-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 45mm Lft 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-0516-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 50mm Rt 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-0521-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 45mm Lft Standard 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-0522-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand 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-0513-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow 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-0514-2015 · Oct 17, 2014 · Terminated
    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off 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.

Other Joint, Temporomandibular, Implant devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.