Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2020 - (Recall #: Z-0790-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Product Classification:

Class II

Date Initiated: November 28, 2018

Date Posted: January 15, 2020

Recall Number: Z-0790-2020

Event ID: 84067

Reason for Recall:

The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.

Status: Completed

Product Quantity: 274 devices

Code Information:

Lot numbers 104479 and 104963.

Distribution Pattern:

Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated