Implant Direct Sybron Manufacturing LLC recalls Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnl…

Recall date

October 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1157-2020

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing LLC

Sold / distributed

US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO

Why it was recalled

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.

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, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,