Z-0718-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- June 16, 2017
- Termination Date
- April 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
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.
Reason for Recall
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
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
Code Information
Catalog Number D-TAP-MAX7-7, Lot 31444