Recall Z-2046-2016— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2016-05-19, terminated 2016-11-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-19
- Terminated
- 2016-11-17
- Firm location
- Westlake Village, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.