TMJ Solutions Inc recalls TMJ Bilateral Implants

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.

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 cmf-pfa@stryker.com Please contact the firm's quality department cmf-pfa@stryker.com with questions or concerns.

• FDA enforcement recordOfficial FDA database entry for Z-2524-2026
• FDA device classification · LZDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3940The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find TMJ Solutions IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.