Class 1 Device Recall TMJ Bilateral Implant

• Date Initiated by Firm: October 13, 2025
• Date Posted: November 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0488-2026
• Recall Event ID: 97703
• PMA Number: P980052
• Product Classification: Joint, temporomandibular, implant - Product Code LZD
• Product: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
• 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
• Recalling Firm/ Manufacturer: TMJ Solutions Inc; 6059 King Dr; Ventura CA 93003-7607
• For Additional Information Contact: Quality Department ; 805-650-3391
• Manufacturer Reason for Recall: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
• FDA Determined Cause: Process control
• Action: 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 .
• Quantity in Commerce: 63 units
• Distribution: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LZD