FDA recall Z-0718-2018

Keystone Dental Inc · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-06-16
Report date
2018-03-07
Termination date
2019-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2018