Class 2 Device Recall BIOMET 3i ART 1036 Dental Implant Radiographic Transparency

• Date Initiated by Firm: November 16, 2015
• Date Posted: December 31, 2015
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-0564-2016
• Recall Event ID: 72658
• Product Classification: Dental Implant Radiographic Transparency - Product Code NDP
• Product: Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
• Code Information: Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.
• Recalling Firm/ Manufacturer: Biomet 3i, LLC; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: Mark Mashburn; 561-776-6700
• Manufacturer Reason for Recall: Images contained within radiographic transparency ART 1036 are undersized.
• FDA Determined Cause: Software design (manufacturing process)
• Action: BIOMET3i sent an" Urgent Medical Device Recall letter " dated November, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Responsibilities: 1. Please review this notice and check your inventory for the affected item by comparing any on-hand ART 1036 Transparencies to a standard 8.5" x 11" sheet of paper. The non-conforming ART 1036 is approximately 7.8" x 10.2". 2. Immediately quarantine and remove all affected items from service. 3. Complete the attached Business Reply Form and either: a. fax it to 561-514-6316 or b. email it to postmarket@biomet.com or c. return it along with the affected product using the included shipping label 4. Return affected product to BIOMET 3i. For assistance or other questions that you may have relative to this notice, please contact BIOMET 3i at 1- 800-342-5454 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.
• Quantity in Commerce: 686
• Distribution: Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
• 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.