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Open, Classified

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.

FDA Recall Z-3264-2024 · Posted 2024-09-26

Recalling FirmTMJ Solutions Inc
Recall StatusOpen, Classified
Product CodeLZD
Date Initiated2024-07-24
Product Quantity1

Reason for Recall

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

Firm Action

On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide distribution in the state of MN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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