Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2019 - (Recall #: Z-0010-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Product Classification:

Class II

Date Initiated: August 7, 2018

Date Posted: October 9, 2019

Recall Number: Z-0010-2020

Event ID: 83086

Reason for Recall:

The incorrect device was packaged in the vial.

Status: Terminated

Product Quantity: 158 devices

Code Information:

Lot 108191, UDI (01)10841307108313(17)230118(10)108191

Distribution Pattern:

Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.

Voluntary or Mandated:

Voluntary: Firm initiated