Exactech, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0132-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.

Product Classification:

Class II

Date Initiated: September 19, 2017

Date Posted: November 29, 2017

Recall Number: Z-0132-2018

Event ID: 78111

Reason for Recall:

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Status: Terminated

Product Quantity: 665 devices

Code Information:

All lot numbers

Distribution Pattern:

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated