Class 2 Device Recall INFINITY Internal Hex Healing Abutment

• Date Initiated by Firm: February 22, 2017
• Date Posted: April 17, 2017
• Recall Status: Terminated on August 07, 2017
• Recall Number: Z-1835-2017
• Recall Event ID: 76604
• 510(K)Number: K093518
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473; ; ; Product Usage:; Non implantable dental abutment.
• Code Information: Lot Number: 16100050
• Recalling Firm/ Manufacturer: Ace Surgical Supply Co., Inc.; 1034 Pearl St; Brockton MA 02301-5411
• For Additional Information Contact: Doreen Price; 800-441-3100 Ext. 208
• Manufacturer Reason for Recall: Incorrect device was packaged.
• FDA Determined Cause: Labeling mix-ups
• Action: ACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.
• Quantity in Commerce: 87
• Distribution: Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
• 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 = DZE and Original Applicant = ACE SURGICAL SUPPLY CO., INC.