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