TMJ Bilateral Implants, REF: CHG020 recallZ-2524-2026 · TMJ Solutions Inc · initiated Feb 11, 2026
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
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
FDA root cause category: Process control
What the company is doing
On 2/11/2026, the customer was contacted and verbally informed of the recall. On 4/23/2026, a recall notice was sent to the customer asking them to take the following action: 1) Inform all appropriate members of your organization who need to be made aware of this action. 2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. 3) Complete and return the Business Reply Form (BRF) via email to [email protected] Please contact the firm's quality department [email protected] with questions or concerns.
Recall details
- Recall number
- Z-2524-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2026
- Posted by the FDA
- Jun 22, 2026
- Recalling firm
- TMJ Solutions Inc
- Quantity
- 1
- Product code
- LZD
- FDA submissions
- P980052
- Distribution
- US Nationwide distribution in the state of MA.
Product description
TMJ Bilateral Implants, REF: CHG020
Code information (models, lots, serial numbers)
UDI-DI: 07613327626575, Lot: 2508181038
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 CHG020TMJ Solutions, Inc. · Joint, Temporomandibular, Implant2 recalls172 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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