TMJ Solutions Inc: Medical Device Recall in 2025 - (Recall #: Z-0488-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Product Classification:

Class I

Date Initiated: October 13, 2025

Date Posted: November 26, 2025

Recall Number: Z-0488-2026

Event ID: 97703

Reason for Recall:

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

Status: Ongoing

Product Quantity: 63 units

Code Information:

UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011

Distribution Pattern:

US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,

Voluntary or Mandated:

Voluntary: Firm initiated