FDAFDA · Food and drugs·Recall number Z-3264-2024
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.
Published October 2, 2024 · Recall initiated: July 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- TMJ Solutions Inc
- Distributor
- US Nationwide distribution in the state of MN.
- Lot
- Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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