Plus Initial Drill, Article Number: 103.170;
Recall
- Recall Number
- Z-1861-2025
- Event Number
- 96798
- Firm
- Straumann USA LLC
- FEI Number
- 1000121052
- Product Code
- DZA
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- April 14, 2025
- Posted
- May 28, 2025
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
Description
Plus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
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.
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.
288 units ($& US, 241 OUS)