Exactech, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0953-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

Product Classification:

Class II

Date Initiated: February 1, 2013

Date Posted: March 27, 2013

Recall Number: Z-0953-2013

Event ID: 64465

Reason for Recall:

A dimensional mismatch was identified which can potentially allow for interference between devices.

Status: Terminated

Product Quantity: 123 devices

Code Information:

Catalog # 02-012-42-3508 All lot numbers

Distribution Pattern:

Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated