Z-1861-2025Class II

Plus Initial Drill, Article Number: 103.170

Name: Z-1861-2025 Plus Initial Drill, Article Number: 103.170
Creator: Straumann USA LLC
Published: 2025-04-14
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2025-04-14 / Open, Classified

FDA source

Straumann USA LLC began a recall of Plus Initial Drill, Article Number: 103.170 on 2025-04-14. FDA classified it as Class II and gives the reason as "The referred batch was produced without the laser engraving of 7 mm". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1861-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-14
Posted: 2025-05-28
Recalling firm: Straumann USA, LLC
Product: Plus Initial Drill, Article Number: 103.170;
Product code: DZA Drill, Dental, Intraoral
Reason for recall: The referred batch was produced without the laser engraving of 7 mm.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 288 units ($& US, 241 OUS)
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 codes and lots: Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1861-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1861-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28

Product code DZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)