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U.S. Department of Health and Human Services

Class 2 Device Recall InterActive Implant OpenTray Transfer Narrow

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  Class 2 Device Recall InterActive Implant OpenTray Transfer Narrow see related information
Date Initiated by Firm May 19, 2016
Create Date June 23, 2016
Recall Status1 Terminated 3 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/
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 2
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.