TMJ Solutions Inc

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0488-2026Class ITMJ Bilateral Implant REF: CHG020 Sterile EO, Rx OnlyOctober 13, 2025
Z-3264-2024Class IIStryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM,July 24, 2024
Z-1444-2018Class IIPatient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction ProsthMarch 12, 2018