—#179712

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150890
Affected lot / code info: Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2020-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.