Brand Name: Inclusive Product Name: Inclusive Titanium Screw… — Class II medical device recall Z-0417-2026
Ongoing recall by Prismatik Dentalcraft, Inc., reported 2025-11-12, distributed in CA, CO, CT, FL, GA, HI, KY, MA…. Incorrect titanium screw, packaged with dental implant.
| Recall number | Z-0417-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prismatik Dentalcraft, Inc., Irvine, CA, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-11-03 |
| Reported by FDA | 2025-11-12 |
| Distributed | CA, CO, CT, FL, GA, HI, KY, MA, MD, MI, NH, NJ, NY, PA, SC, TN, VA, WA |
| Quantity | 208 units |
| Lot numbers | 6270484, 6271089 |
| Model numbers | 6270484, 6271089, 70-1047-COM0117 |
Product
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Reason for recall
Incorrect titanium screw, packaged with dental implant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0417-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.