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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