Plus Initial Drill, Article Number: 103.170 recallZ-1861-2025 · Straumann USA LLC · initiated Apr 14, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The referred batch was produced without the laser engraving of 7 mm.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 14, 2025 customers were notified via phone with a follow-up letter sent on April 28, 2024. Both contacts included the following: Action to be taken: 1. If article 103.170 from lot LNWT8 is still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If the product was used and no complications or problems were identified, of the patient did not present symptoms there is no need for any additional action with the patient. 3. If article 103.170 from Lot LNWT8 is still in your inventory, return it for a credit or replacement as indicated on the Customer Confirmation Form. 4. In the product is not found in your stock, indicate this on the enclosed Customer Confirmation Form. 5 In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810. transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The FDA has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
Recall details
- Recall number
- Z-1861-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2025
- Posted by the FDA
- May 28, 2025
- Recalling firm
- Straumann USA LLC
- Quantity
- 288 units ($& US, 241 OUS)
- Product code
- DZA
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Portugal, Romania, Spain, Switzerland, Ukraine.
Product description
Plus Initial Drill, Article Number: 103.170;
Code information (models, lots, serial numbers)
Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neodent 103.170JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page