Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC

• Date Initiated by Firm: March 11, 2013
• Date Posted: March 20, 2013
• Recall Status: Terminated on September 26, 2013
• Recall Number: Z-0973-2013
• Recall Event ID: 64633
• 510(K)Number: K051614
• Product Classification: Accessories, implant, dental, endosseous - Product Code NDP
• Product: PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
• Code Information: Lot Number: 12857
• Recalling Firm/ Manufacturer: Keystone Dental Inc; 144 Middlesex Tpke; Burlington MA 01803-4403
• For Additional Information Contact: Jamie Picariello; 781-328-3390
• Manufacturer Reason for Recall: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
• FDA Determined Cause: Packaging process control
• Action: Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
• Quantity in Commerce: 120 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NDP