FDA Medical Device Recalls (openFDA)
Straumann USA LLC: Plus Initial Drill, Article Number: 103.170;
- Recall number
- Z-1861-2025
- Recalling firm
- Straumann USA LLC
- Product
- Plus Initial Drill, Article Number: 103.170;
- Status
- Open, Classified
- Initiated
- 2025-04-14
- Posted
- 2025-05-28
- Terminated
- not on file
- Reason
- The referred batch was produced without the laser engraving of 7 mm.
- 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
- 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.
- Lot, serial or model codes
- Article Number: 103.170; UDI-DI: (01)7898237561967(11)250204(17)400204(10)LNWT8; Lot Number: LNWT8
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZA
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28