Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2018 - (Recall #: Z-1917-2018)

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:

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Product Classification:

Class II

Date Initiated: March 14, 2018

Date Posted: May 30, 2018

Recall Number: Z-1917-2018

Event ID: 79793

Reason for Recall:

The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

Status: Terminated

Product Quantity: 298 implants

Code Information:

Lot #68960

Distribution Pattern:

Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated