Recall Z-2046-2016 ยท EHY Tray, Impression, Preformed
Implant Direct Sybron Manufacturing, LLC
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.
| Date | May 19, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.