Medical device recalls Moderate risk

TMJ Solutions Inc recalls Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mod…

Recall date
July 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3264-2024
FDA classification
Class II
Brand / firm
TMJ Solutions Inc
Sold / distributed
US Nationwide distribution in the state of MN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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