🔍 RecallPedia

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Class I - Dangerous
🏥 Medical Devices Recalled: October 13, 2025 TMJ Solutions Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    UDI: (01)07613327626575/ 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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TMJ Solutions Inc
Reason for Recall:
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Product Codes/Lot Numbers:

UDI: (01)07613327626575/ 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:

Distributed in: US, IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0488-2026

Related Recalls

Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion

TMJ Solutions

Class I - Dangerous

This device was mislabeled and is not the correct component for this patient.

Mar 12, 2018 Implants & Prosthetics View Details →