Recall – Orthopedic implant system navigation software incorrectly calculates depth

Company: Intellijoint Surgical, Inc.
Date of Enforcement Report: 4/1/2020
Class II

PRODUCT

Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) – Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

  • Recall Number: Z-1559-2020

REASON

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

RECALLING FIRM/MANUFACTURER

Intellijoint Surgical, Inc. on 2/11/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

US Nationwide and International

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