Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2018 - (Recall #: Z-0089-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Product Classification:

Class II

Date Initiated: May 29, 2018

Date Posted: October 17, 2018

Recall Number: Z-0089-2019

Event ID: 80297

Reason for Recall:

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

Status: Terminated

Product Quantity: 217 units

Code Information:

Part number 8735-05, Lot number 90212

Distribution Pattern:

Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

Voluntary or Mandated:

Voluntary: Firm initiated