Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in U

Recalled November 20, 2019 · FDA recall Z-0364-2020 · Implant Direct Sybron Manufacturing

Hazard

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. · FDA Class II

Units

23 implants

Sold at

U.S.: IN, VA, MD, TX, WA OUS: Japan

Description

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

Product

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Manufacturer(s)

Implant Direct Sybron Manufacturing, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →