Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2018 - (Recall #: Z-2376-2018)

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:

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

Product Classification:

Class II

Date Initiated: May 18, 2018

Date Posted: July 11, 2018

Recall Number: Z-2376-2018

Event ID: 80281

Reason for Recall:

Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

Status: Terminated

Product Quantity: 60 units

Code Information:

Lot numbers: 45353, 66011, and 75850

Distribution Pattern:

CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland

Voluntary or Mandated:

Voluntary: Firm initiated