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TMJ Solutions Inc: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Medical DevicesSource: FDA (device) · Date: 2025-11-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
TMJ Solutions Inc
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason / hazard
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Classification
Class I
Status
Ongoing
Distribution / sold at
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Recall initiated
2025-10-13
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
Product quantity
63 units
Voluntary mandated
Voluntary: Firm initiated
City
Ventura
State
CA
Country
United States
Event id
97703
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