Exactech, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1364-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.

Product Classification:

Class II

Date Initiated: January 27, 2020

Date Posted: March 4, 2020

Recall Number: Z-1364-2020

Event ID: 84961

Reason for Recall:

These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.

Status: Ongoing

Product Quantity: 4 units

Code Information:

Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076

Distribution Pattern:

US Nationwide distribution in the states of AZ, CO and FL.

Voluntary or Mandated:

Voluntary: Firm initiated