FDAJuly 24, 2024device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

tmj solutionstmj

UPCs

0761332762780007613327625551

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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