FDA Enforcement
Class I
Ongoing
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Recall: Z-0488-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0488-2026
- Event ID
- 97703
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TMJ Solutions Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 26, 2025
- Initiation Date
- October 13, 2025
- Classification Date
- November 14, 2025
- Address
- 6059 King Dr, Ventura, CA, 93003-7607, United States
Description
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Code Info
UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011
Distribution
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Quantity
63 units