Z-2046-2016Class II

6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N

Name: Z-2046-2016 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-05-19
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-05-19 / Terminated / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of 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... on 2016-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2046-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-19
Posted: 2016-06-23
Terminated: 2016-11-17
Recalling firm: Implant Direct Sybron Manufacturing LLC
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.
Product code: EHY Tray, Impression, Preformed
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.
Root cause tag: packaging
FDA 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 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
Product codes and lots: Lot #71664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-23

Product code EHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)