Z-1364-2020Class II

Truliant Splined Stem Extension, 18mm x 120mm -

Name: Z-1364-2020 Truliant Splined Stem Extension, 18mm x 120mm -
Creator: Exactech, Inc.
Published: 2020-01-27
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2020-01-27 / Open, Classified / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral... on 2020-01-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1364-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-01-27
Posted: 2020-02-26
Recalling firm: Exactech, Inc.
Product: 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 code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Exactech distributed the recall notice to the consignees in possession of affected inventory by electronic mail on 7 January 2020. In order to comply with the notice, consignees have been instructed to: "Immediately cease distribution or use of this product. "Extend the information to their accounts that may have this product in their possession. "Identify and quarantine any of the subject devices in their inventory "Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of AZ, CO and FL.
Product codes and lots: Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1364-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1364-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-03-04	2020-02-26

Product code JWH

K150890Class IIExactech Optetrak Logic CCExactech, Inc. / cleared 2015-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)