Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
This recall involves correcting devices where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that Stryker has issued letters to affected customers recommending certain TMJ Unilateral and Bilateral Implants have updated instructions for use.
| Catalog Number | Product Description | UDI |
|---|---|---|
| CHG010 | TMJ Unilateral Implant | 07613327626551 |
| CHG024 | TMJ Unilateral Implant, Oversized | 07613327626605 |
| CHG031 | TMJ Unilateral Implant, ALL TI | 07613327627749 |
| CHG020 | TMJ Bilateral Implant | 07613327626575 |
| CHG026 | TMJ Bilateral Implant, Oversized | 07613327626568 |
| CHG032 | TMJ Bilateral Implant, ALL TI | 07613327627848 |
What to Do
Continue to monitor patients with the implant according to your follow-up protocols. If an affected TMJ Implant device remains in inventory and has not been implanted, contact Stryker.
On September 30, 2025, Stryker issued an "Urgent: Medical Device Recall" notification to affected consignees. On December 4, 2025 and February 25, 2026, Stryker issued expansion notifications to additional customers. These notifications recommended the following actions:
- Continue to monitor patients implanted with this device consistent with your follow-up protocols.
- If the affected TMJ Implant device remains in inventory and has not been implanted, contact Stryker at cmf-pfa@stryker.com.
- Inform individuals within your organization who need to be aware of this action. Maintain awareness of this communication internally until all required actions have been completed within your facility.
Reason for Correction
Stryker stated that they received a report that during surgery to implant the device, a 6mm screw was placed in an approximately 2.6mm thick bone, which penetrated the cranial vault.
There is a discrepancy in the positioning of the screw hole between what was specified in the design specification sheet and the actual fossa design. This may result in the recommended screw length being greater than the bone thickness for implants with screw holes located in an area of thin bone and penetration of the cranial vault. Penetration of the cranial vault could lead to dural tissue damage, bleeding, cerebral spinal fluid leak (CSF), or meningitis. Use of an affected device could require intervention to prevent serious injury.
As of December 4, Stryker has reported one serious injury and no deaths associated with this issue.
Device Use
The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Stryker at cmf-pfa@stryker.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.