Recall Z-1861-2025 ยท DZA Drill, Dental, Intraoral
Straumann USA LLC
Plus Initial Drill, Article Number: 103.170;
| Date | May 28, 2025 (initiated Apr 14, 2025) |
| Status | Open, Classified |
| 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 in |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.