Keystone Dental Max Implant Bone Tap: 8mm Marked as 7mm Diameter Risk
Keystone Dental recalls Bone Tap (Catalog D-TAP-MAX7-7) that was laser marked 8mm but labeled 7mm. This mismatch risks improper implant fitting. Affected units sold with specific catalog and lot numbers.
Lower-risk recall
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Contact the company
What happened, in plain English
Keystone Dental is recalling Bone Taps labeled 7mm but actually 8mm in diameter. Using these could cause improper dental implant fitting, potentially leading to complications. Read more at govinfonow.com/recall/73830-keystone-dental-max-implant-bone-tap-8mm-marked-as-7mm.
Source Summary by GovInfoNow · govinfonow.com/recall/73830-keystone-dental-max-implant-bone-tap-8mm-marked-as-7mm · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0718-2018
Cite this page
“Keystone Dental Max Implant Bone Tap: 8mm Marked as 7mm Diameter Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73830-keystone-dental-max-implant-bone-tap-8mm-marked-as-7mm. Based on FDA recall #Z-0718-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0718-2018%22&limit=1).
Why it’s dangerous
The Bone Tap was laser marked as 8mm but labeled 7mm. This mismatch means it may not fit properly with 7.0mm implants, potentially causing improper implant placement or damage.
Who’s affected
Dental patients using Keystone Dental's Max Implant System Bone Tap (Catalog D-TAP-MAX7-7) with 7.0mm diameter implants. Patients with dental crowns, bridges, or overdentures are most at risk.
How to tell if you have this one
Check for Catalog Number D-TAP-MAX7-7 and Lot 31444 on the Bone Tap. The product is sold for dental implants with 7.0mm diameter.
- Brand
Keystone Dental- Category
Medical device
What to do — step by step
Check Product Label
Look for Catalog Number D-TAP-MAX7-7 and Lot 31444 on the Bone Tap.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
FDA distribution: “USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 22 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.
Questions people ask
Is this recall dangerous?
The recall is for a labeling error that could lead to improper implant fitting, but it does not pose an immediate risk of serious injury.
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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-0718-2018 (June 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0718-2018 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.