TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reported: November 26, 2025 Initiated: October 13, 2025 #Z-0488-2026
Product Description
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason for Recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Details
- Recalling Firm
- TMJ Solutions Inc
- Units Affected
- 27 units
- Distribution
- US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
- Location
- Ventura, CA
Frequently Asked Questions
What product was recalled? ▼
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only. Recalled by TMJ Solutions Inc. Units affected: 27 units.
Why was this product recalled? ▼
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Critical. Recall number: Z-0488-2026.
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