On June 30, 2015, the Food and Drug Administration’s Center of Devices & Radiological Health sent a warning letter to the President of Nexus CMF telling him that, “Nexus CMF has committed a prohibited act under section 301(q)(1)(c) of the Act by failing to comply with requirements under section 522 of the Act, and your P000023and P00035 devices are currently misbranded under section 502(t)(3) of the Act. It is also a prohibited act under section 301(a) of the Act to introduce or deliver for introduction a misbranded device into interstate commerce.”
The TMJ Association recently learned of this warning letter and verified with the FDA on November 11, 2015 that this letter is still in effect. Click here to view the warning letter.
Nexus CMF is formerly TMJ Medical, formerly TMJ Implants, Inc., and commonly referred to as the Christensen device.
What this means for patients…
Nexus CMF is currently prohibited from selling their TMJ total and partial joints to patients, surgeons and hospitals. If you or someone you know has received this implant after June 30, 2015 or is anticipating getting one in the near future, you should report this to the FDA’s MedWatch system. Please feel free to contact the TMJ Association at firstname.lastname@example.org if you need any assistance with completing a report or would like to file it anonymously.
We’d like to remind patients that any time you experience problems or adverse events related to TMJ devices, including splints and jaw implants, it’s important to notify the FDA of these issues through the MedWatch system. You can view TMJ implant complaints and problems filed by others through the MedWatch system at the FDA's Maude Report website.