Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2016 - (Recall #: Z-2046-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 19, 2016

Date Posted: June 29, 2016

Recall Number: Z-2046-2016

Event ID: 74208

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.

Status: Terminated

Product Quantity: 48

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

Voluntary or Mandated:

Voluntary: Firm initiated