Medical device recalls Moderate risk

Implant Direct Sybron Manufacturing LLC recalls Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Recall date
October 7, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1041-2020
FDA classification
Class II
Brand / firm
Implant Direct Sybron Manufacturing LLC
Sold / distributed
U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP

Why it was recalled

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

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

What was recalled

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

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