Recall Z-3264-2024— TMJ Solutions Inc
Class II · Ongoing
Class II FDA medical device recall by TMJ Solutions Inc, initiated 2024-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO.
- Recalling firm
- TMJ Solutions Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-24
- Firm location
- Ventura, CA, United States
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.
Reason for recall
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Data sourced from openFDA. This site is unofficial and independent of the FDA.