“Implant Direct dental implants: Cap mislabeled part number.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70940-implant-direct-dental-implants-cap-mislabeled-part-number. Based on FDA recall #Z-0089-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2019%22&limit=1).
Implant Direct Sybron Manufacturing LLC voluntarily recalled its Legacy Implant Closed-Tray Transfer-Concave Profile dental implant component due to potential mislabeling of the cap with an incorrect part number, according to the FDA on May 29, 2018.
How to tell if you have it
Brand: Implant Direct
Product: Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform
Part number: 8735-05
Lot number: 90212
The hazard
The cap may be mislabeled with an incorrect part number, although the correct part number is on the main vial label.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Straumann GM Helix Dental Implant Recall (July 13, 2026), EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (Jan. 15, 2026), and Encore Medical RSP Humeral Socket Insert Recall: Incorrect Labeling Hazard (Jan. 15, 2026).
How to tell if you have this one
Check for part number 8735-05 and lot number 90212 on the main vial label. The product was sold as a dental implant component used temporarily during impressions.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cap Label
Verify the part number on the main vial label matches the correct part number (8735-05).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0089-2019 (May 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0089-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.