Titanium Screw Recall: Inclusive 70-1047-COM0117
Announced 2026-07-29 · FDA
The recall involves 208 units of an incorrect titanium screw packaged with a dental implant. The product is the Inclusive Titanium Screw compatible with Biomet 3i, Catalog 70-1047-COM0117, Lot Numbers 6270484 and 6271089; it was distributed in the US to listed states. The FDA recall notice includes UDI and SKU details, but no corrective action is specified.
| Brand | Prismatik Dentalcraft, Inc. |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 20 |
| Distribution | US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089 |
WHAT YOU SHOULD DO
- Do not use the affected screws.
- Check if you have catalog number 70-1047-COM0117 or lot numbers 6270484/6271089; contact your dental professional or Prismatik Dentalcraft for return/replacement instructions.
- Follow FDA/manufacturer guidance for recall actions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.