Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.

FDA Recall Z-0985-2009 · Posted 2009-03-02

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2008-08-19
Date Terminated2010-04-28
Product Quantity75 (34 U.S. and 41 international)

Reason for Recall

Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for

Firm Action

Zimmer notified consignees via letter dated 8/19/08, which advised them not to change the selected surgeon profile after the acquisition of landmarks has begun, and the issued will be fixed with the next software release.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003Orthosoft, Inc. · 2007-07-20

Official Source

View FDA Recall →

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

↑