Recall Z-1862-2025 ยท DZE Implant, Endosseous, Root-Form
Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.984
| Date | May 28, 2025 (initiated May 1, 2025) |
| Status | Open, Classified |
| Reason | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| Root cause | Under Investigation by firm |
| Action | On May 1, 2025 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are 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 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, return it for a credit or replacement as indicated on the Customer Confir |
| Quantity | 300 units (125 US, 175 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, Uni |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163194 | Neodent Implant System - GM Line Jjgc Industria E Comercio DE Materiais Dentarios S.A., Jul 14, 2017 |