Medical device recalls Moderate risk

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…

Recall date
August 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0364-2020
FDA classification
Class II
Brand / firm
Implant Direct Sybron Manufacturing, LLC
Sold / distributed
U.S.: IN, VA, MD, TX, WA OUS: Japan

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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