TMJ Solutions Inc: Device Recall
Recall #Z-3264-2024 · 07/24/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3264-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- TMJ Solutions Inc
- Status
- Ongoing
- Date Initiated
- 07/24/2024
- Location
- Ventura, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Reason for Recall
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Product Description
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Distribution Pattern
US Nationwide distribution in the state of MN.
Other Recalls by TMJ Solutions Inc
- Class I: Dangerous 10/13/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.