Inclusive recalls titanium screws that may be incorrectly packaged with dental implants. This could cause improper implant fitting. Affected units include specific model numbers and lot codes.
“Inclusive Titanium Screw Recall: Incorrect Dental Implant Screw Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51149-inclusive-titanium-screw-recall-incorrect-dental-implant-screw-hazard. Based on FDA recall #Z-0417-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2026%22&limit=1).
The FDA announced on Sept. 30, 2025, that Prismatik Dentalcraft, Inc. is recalling Inclusive Titanium Screws compatible with Biomet 3i implants due to the incorrect screw being packaged with the dental implant. The agency issued recall number Z-0417-2026 for the Class II voluntary recall.
Sold in California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington
The hazard
The recall involves dental implants packaged with an incorrect titanium screw. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Prismatik Dentalcraft, Inc. has issued two other recalls since April 14, 2025, including a Silent Nite Sleep Appliance recall on April 27, 2026, for missing FDA clearance and a Glidewell HT Implant Twist Drill recall on April 14, 2025, due to packaging mix-ups. Other recent recalls of similar products include the Straumann Dental Implant Abutments Recall (March 27, 2026) and the Straumann GM Helix Dental Implant Recall (July 13, 2026).
How to tell if you have this one
Check for model number 70-1047-COM0117 or lot numbers 6270484, 6271089 on the screw packaging. These screws are sold with Biomet 3i implants for specific sizes (3.4/4.1/5.0/6.0 mm).
Brand
Inclusive
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number 70-1047-COM0117 or lot numbers 6270484, 6271089 on the screw packaging.
Where it went and when
Where it was distributed
Distributed in 18 states.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0417-2026 (September 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0417-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.