Exactech, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1208-2019)

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:

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Product Classification:

Class II

Date Initiated: March 13, 2019

Date Posted: May 1, 2019

Recall Number: Z-1208-2019

Event ID: 82480

Reason for Recall:

2.5 Truliant Fit Trays were mismarked as 3

Status: Terminated

Product Quantity: 18 units

Code Information:

Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543

Distribution Pattern:

US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL

Voluntary or Mandated:

Voluntary: Firm initiated