Z-2524-2026Class II

TMJ Bilateral Implants, REF: CHG020

Name: Z-2524-2026 TMJ Bilateral Implants, REF: CHG020
Creator: TMJ Solutions Inc
Published: 2026-02-11
License: https://open.fda.gov/license/

TMJ Solutions, LLC / initiated 2026-02-11 / Open, Classified / root cause: manufacturing process

FDA source

TMJ Solutions Inc began a recall of TMJ Bilateral Implants, REF: CHG020 on 2026-02-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2524-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-11
Posted: 2026-06-22
Recalling firm: TMJ Solutions, LLC
Product: TMJ Bilateral Implants, REF: CHG020
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: UDI-DI: 07613327626575, Lot: 2508181038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2524-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2524-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-22

Product code LZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)