Z-0973-2013 Class II Terminated

Recalled by Keystone Dental Inc — Burlington, MA

Recall Details

Product Type
Devices
Report Date
March 27, 2013
Initiation Date
March 11, 2013
Termination Date
September 26, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 units

Product Description

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Reason for Recall

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Distribution Pattern

Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.

Code Information

Lot Number: 12857