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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.