TMJ Solutions Inc recalls TMJ Bilateral Implant REF: CHG020 Sterile EO

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

On February 25, 2026 Stryker (TMJ Solutions) issued a " Urgent: Medical Device Recall" Expansion notification to additional, affected consignees. Initial notification and previous expansion was issued on September 30, 2025 and December 4, 2025. TMJ Solutions asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility .

• FDA enforcement recordOfficial FDA database entry for Z-0488-2026
• 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.