Keystone Dental Inc recalls Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are…

Recall date

June 16, 2017

Source

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

Recall number

Z-0718-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada

Why it was recalled

An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

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

What was recalled

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.