Titanium Screw Recall: Inclusive 70-1047-COM0117
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089 |
|---|---|
| Lot / date codes | Item Number: NITESL UDI-DI code: D745SILNT0 Lot/Serial Numbers: 1020214577 1020784354 1030007997 1030439672 1030523763 1030722759 1106770735 1107310424 1107642834 1108530251 1110784932 1117400787 1118814629 1121913952 1122251905 1122958036 1124408531 1125495087 1127571733 1131149684 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.