Recalls / —

—#213694

Product

Plus Initial Drill, Article Number: 103.170;

FDA product code

DZA — Drill, Dental, Intraoral

Device class

Class 1

Medical specialty

Dental

Affected lot / code info

Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

Why it was recalled

The referred batch was produced without the laser engraving of 7 mm.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Straumann USA LLC

Address

60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-04-14

Posted by FDA

2025-05-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #213694. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.