FDA Device recall Z-0417-2026
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: 7…
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of 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: 7… by Prismatik Dentalcraft, citing incorrect titanium screw, packaged with dental implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0417-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-30 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Prismatik Dentalcraft |
| Distribution | CA, CO, CT, FL, GA, HI, KY, MA, MD, MI, NH, NJ, NY, PA, SC, TN, VA, WA |
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
Incorrect titanium screw, packaged with dental implant.
Identifiers
| code_info | Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2026%22
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