FDA-Device2025-11-26Class IPROCESSING DEFECT
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Hazard
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Affected count
63 units
Manufactured in
6059 King Dr, Ventura, CA, United States
Products
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2026More TMJ Solutions recalls
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