Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2019 - (Recall #: Z-0261-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958

Product Classification:

Class II

Date Initiated: September 6, 2018

Date Posted: November 6, 2019

Recall Number: Z-0261-2020

Event ID: 83573

Reason for Recall:

The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.

Status: Terminated

Product Quantity: 107 Scan Adapters

Code Information:

Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511

Distribution Pattern:

US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,

Voluntary or Mandated:

Voluntary: Firm initiated