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Recall Observatory FDA recall evidence

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.

Z-0718-2018

June 16, 2017

Class II

Product summary

Firm
Keystone Dental Inc
Event
Event 79066
Status
Terminated
Classification
Class II
Quantity
72
Official record key
device-enforcement:Z-0718-2018

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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