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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
Recalled March 7, 2018 · FDA recall Z-0718-2018 · Keystone Dental
Hazard
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. · FDA Class II
Units
72
Sold at
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
Description
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Product
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.
Manufacturer(s)
Keystone Dental Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →