TMJ Bilateral Implants, REF: CHG020

FDA device recall Z-2524-2026 · posted 2026-06-22 · Open, Classified

Recall details

Recalling firm

TMJ Solutions Inc

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

LZD

Quantity affected

1

Distribution

US Nationwide distribution in the state of MA.

Date initiated

2026-02-11

Date posted

2026-06-22

Location

Ventura, CA