Keystone Dental Inc: Medical Device Recall in 2018 - (Recall #: Z-0718-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 16, 2017

Date Posted: March 7, 2018

Recall Number: Z-0718-2018

Event ID: 79066

Reason for Recall:

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

Status: Terminated

Product Quantity: 72

Code Information:

Catalog Number D-TAP-MAX7-7, Lot 31444

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated