TMJ Bilateral Implant (TMJ Solutions) – Screw Hole Discrepancy (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Brand
TMJ Solutions Inc
Lot Codes / Batch Numbers
UDI: (01)07613327626575/ Lot # 2410301062
Products Sold
UDI: (01)07613327626575/ Lot # 2410301062
TMJ Solutions Inc is recalling TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only due to Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Recommended Action
Per FDA guidance
On September 30, 2025 Stryker (TMJ Solutions) issued a "Urgent: Medical Device Recall" notification to affected consignees. 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 .
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026