Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2024-07-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3264-2024
Date of alert: 2024-07-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TMJ Solutions Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 101432374

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall 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.

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