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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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