Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2018 - (Recall #: Z-1920-2018)

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 Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

Product Classification:

Class II

Date Initiated: November 15, 2016

Date Posted: May 30, 2018

Recall Number: Z-1920-2018

Event ID: 79885

Reason for Recall:

The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.

Status: Terminated

Product Quantity: 18 units

Code Information:

Lot #71729

Distribution Pattern:

Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated