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Open, Classified

TMJ Bilateral Implants, REF: CHG020

FDA Recall Z-2524-2026 · Posted 2026-06-22

Recalling FirmTMJ Solutions Inc
Recall StatusOpen, Classified
Product CodeLZD
Date Initiated2026-02-11
Product Quantity1

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of MA.

Official Source

View FDA Recall →

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

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