Class 2 Device Recall InterActive Implant OpenTray Transfer Narrow

• Date Initiated by Firm: May 19, 2016
• Create Date: June 23, 2016
• Recall Status: Terminated on November 17, 2016
• Recall Number: Z-2046-2016
• Recall Event ID: 74208
• Product Classification: Tray, impression, preformed - Product Code EHY
• Product: 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow; Part Number: 6534-08N ; ; Product Usage:; Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the laboratory technician.
• Code Information: Lot #71664
• Recalling Firm/ Manufacturer: Implant Direct Sybron Manufacturing, LLC; 3050 E Hillcrest Dr; Westlake Village CA 91362-3171
• For Additional Information Contact: 818-444-3300 Ext. 3323
• Manufacturer Reason for Recall: The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
• FDA Determined Cause: Packaging
• Action: The firm sent out customer notificaiton letters on 05/19/16 via FedEx. Customers were asked to reivew the table to determine if they have any of the affected product in inventory. Customers were being informed that the proper product was being sent with the notificaiton. Customers were asked to complete and return the the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, the firm requests that they identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with the correct tool.
• Quantity in Commerce: 48
• Distribution: Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
• 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.