Keystone Dental: Multi-Unit Implants with Screw Fit Issue
Keystone Dental recalls specific dental implants due to abutments failing to accept final screws. Affected units have catalog number 45324K and lot 33006.
Lower-risk recall
Abutments are unable to accept the final abutment screw
Contact the company
What happened, in plain English
Keystone Dental is recalling certain dental implants because the abutments don't fit properly with the final screw. This could lead to improper dental restoration and potential complications during treatment. Read more at govinfonow.com/recall/73822-keystone-dental-multi-unit-implants-with-screw-fit-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/73822-keystone-dental-multi-unit-implants-with-screw-fit-issue · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0608-2018
Cite this page
“Keystone Dental: Multi-Unit Implants with Screw Fit Issue.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73822-keystone-dental-multi-unit-implants-with-screw-fit-issue. Based on FDA recall #Z-0608-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0608-2018%22&limit=1).
Why it’s dangerous
The abutments in these implants cannot securely accept the final abutment screw. This may cause the implant to become loose or fail during dental procedures, leading to improper restoration.
Who’s affected
Dentists and dental clinics using the recalled implants (catalog number 45324K, lot 33006) are most at risk. Patients receiving these implants may experience improper fit.
How to tell if you have this one
Check for the catalog number 45324K and lot number 33006 on the implant packaging. These implants are used in partially or fully edentulous jaws for dental restorations.
- Brand
Keystone Dental- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number and lot number on the implant packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide Distribution in the states of ND, NJ & MA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Massachusetts, New Jersey, North Dakota.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0608-2018 (June 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0608-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.