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Open, Classified

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

FDA Recall Z-0488-2026 · Posted 2025-11-14

Recalling FirmTMJ Solutions Inc
Recall StatusOpen, Classified
Product CodeLZD
Date Initiated2025-10-13
Product Quantity63 units

Reason for Recall

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

Firm 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 .

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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