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Recall Observatory FDA recall evidence

Device 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.

Z-2046-2016

May 19, 2016

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 74208
Status
Terminated
Classification
Class II
Quantity
48
Official record key
device-enforcement:Z-2046-2016

Official wording

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.

Code information: Lot #71664

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.