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Open, Classified

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.

FDA Recall Z-1364-2020 · Posted None

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2020-01-27
Product Quantity4 units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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