Ventura, CA, United States
TMJ Solutions Inc recalls
4 recalls recorded since 2018, most recently on 11 February 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 11 February 2026
- Reason
- Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
- Distribution
- US Nationwide distribution in the state of MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2524-2026
- TMJ Bilateral Implants, REF: CHG020
Ongoing Class I Medical devices
- Recall started
- 13 October 2025
- Reason
- Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
- Distribution
- US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0488-2026
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Ongoing Class II Medical devices
- Recall started
- 24 July 2024
- Reason
- Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- Distribution
- US Nationwide distribution in the state of MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3264-2024
- Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, R
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 23 July 2019
- Reason
- This device was mislabeled and is not the correct component for this patient.
- Distribution
- US Distribution to GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1444-2018
- Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is inte
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.