Implant Direct Sybron Manufacturing LLC: Medical Device Recall in 2021 - (Recall #: Z-0198-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Product Classification:

Class II

Date Initiated: September 23, 2021

Date Posted: November 10, 2021

Recall Number: Z-0198-2022

Event ID: 88859

Reason for Recall:

Packaged dental implant contains a different size then the size declared on the labeling.

Status: Ongoing

Product Quantity: 83 implants

Code Information:

lot # 166300 / UDI: 10841307101796

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated