medical Class II Updated 2024-10-02

TMJ Solutions Inc recalls Stryker TMJ Unilateral Implant, REF: GHG010, consisting of

Recalled 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.


Hazard / Issue

Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
View official government recall

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