Summary
The FDA issued a Class I for TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only by TMJ Solutions Inc. Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position..
Details
Source
Device Recall
External ID
Z-0488-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Lot/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
Quantity Affected: 63 units
Reason for Recall
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,
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-13
Company
Ventura, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TMJ Solutions Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TMJ Solutions Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TMJ Solutions Inc have FDA actions?
TMJ Solutions Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0488-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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