Lower riskMedical device recall · FDA · Published October 11, 2019
Implant Direct Legacy 3 Implant Recall: Incorrect Cover Screw May Delay Surgery
Implant Direct recalls Legacy 3 implants with incorrect cover screw that may delay surgery or require new procedures. Affected units have specific size and lot numbers.
Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.
Take action
Contact the company
📍Recalling firmImplant Direct Sybron Manufacturing LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
“Implant Direct Legacy 3 Implant Recall: Incorrect Cover Screw May Delay Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66798-implant-direct-legacy-3-implant-recall-incorrect-cover-screw-may. Based on FDA recall #Z-1157-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2020%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled Implant Direct dental implants distributed in the U.S. due to incorrect cover screws and extenders, according to the FDA. The agency announced the recall on Oct. 11, 2019.
How to tell if you have it
Brand: Implant Direct
Product: CE 0086, REF: 855710, Legacy 3 Impant
Surface: SBM
Size: 5.7mmD x 10mmL, 5.7mmD Platform
Lot #: 68209
The hazard
Internal investigation and customer complaints revealed that some packages contained incorrect cover screws and extenders. This error could result in surgery delays or require new surgical procedures to place the correct parts, according to the FDA.
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 Sybron Drill Stop Kit Recall (May 1, 2025), Sybron Legacy Smartbase Recalls (May 2, 2023), Implant Direct Legacy 2 Dental Implant Recall (Sept. 23, 2021), Straumann Dental Implant Abutments Recall (March 27, 2026), and Tornier Perip Screw Recall (Dec. 19, 2025).
How to tell if you have this one
Check for the Legacy 3 implant with size 5.7mmD x 10mmL and lot number 68209. The product is labeled as RxOnly, Sterile R, and has the CE 0086 certification.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Implant Package
Verify the lot number on the implant package to confirm if it is affected (lot # 68209).
Where it went and when
Where it was distributed
Distributed in 23 states.
Listed by the agency
Not listed
FDA distribution: “US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Georgia, Idaho, Illinois, Indiana, Kentucky, Maryland, Missouri, Nevada, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oregon, Pennsylvania, Texas, Utah, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.5 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-1157-2020 (October 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1157-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.