CLASS I ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
TMJ Bilateral Implant recalled by TMJ Solutions
TMJ Solutions is recalling TMJ Bilateral Implant, distributed in 15 states. The recall was initiated on 13 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0488-2026
- FDA event ID
- 97703
- Recalling firm
- TMJ Solutions, Ventura, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Oct 2025
- FDA classified
- 14 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Oct 2025 | Recall initiated by company | |
| 14 Nov 2025 | Classified by FDA | +32 days |
| 26 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Product as listed by the FDA
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Where it was distributed
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
CaliforniaFloridaGeorgiaIllinoisMassachusettsMarylandMinnesotaMississippiNew YorkOklahomaOregonPennsylvaniaTexasUtahVirginia
Questions about this recall
Why was it recalled?
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Which lots are affected?
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
Where was it sold?
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TMJ Solutions
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TMJ Bilateral Implants recalled by TMJ Solutions | TMJ Solutions | Other | Nationwide |
| Device | CLASS II | Stryker TMJ Unilateral Implant recalled by TMJ Solutions | TMJ Solutions | Other | Nationwide |
| Device | CLASS II | Patient-Fitted Temporomandibular recalled by TMJ Solutions | TMJ Solutions | Labeling Errors | GA |
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