Stryker TMJ Unilateral Implant, REF: GHG010, consisting of… recallZ-3264-2024 · TMJ Solutions Inc · initiated Jul 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TMJ Solutions Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
FDA root cause category: Mixed-up of materials/components
What the company is doing
On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.
Recall details
- Recall number
- Z-3264-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2024
- Posted by the FDA
- Sep 26, 2024
- Recalling firm
- TMJ Solutions Inc
- Quantity
- 1
- Product code
- LZD
- Distribution
- US Nationwide distribution in the state of MN.
Product description
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.
Code information (models, lots, serial numbers)
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG010AMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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