FDAFDA · Food and drugs·Recall number Z-0718-2018
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.
Published March 7, 2018 · Recall initiated: June 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Keystone Dental Inc
- Distributor
- 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
- Lot
- Catalog Number D-TAP-MAX7-7, Lot 31444
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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