Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on…

Recall date

August 7, 2018

Source

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

Recall number

Z-0010-2020

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.

Why it was recalled

The incorrect device was packaged in the vial.

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

What was recalled

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.