Recall Z-1364-2020— Exactech, Inc.

Name: FDA recall Z-1364-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-27

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2020-01-27. It names one FDA 510(k) clearance: K150890. 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.. Reason: 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..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-01-27
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K150890 — Exactech Optetrak Logic CCExactech, Inc.·cleared 2015-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.