Recall Z-2075-2017— Orthosoft, Inc. dba Zimmer CAS

Name: FDA recall Z-2075-2017
Creator: U.S. Food and Drug Administration
Published: 2008-06-20

Class III · Terminated

Class III FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2008-06-20, terminated 2017-05-15. It names one FDA 510(k) clearance: K060336. Product: Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument. Reason: ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3..

Recalling firm: Orthosoft, Inc. dba Zimmer CAS
Classification: Class III
Status: Terminated
Initiated: 2008-06-20
Terminated: 2017-05-15
Firm location: Montreal, Canada

510(k) clearances named in this recall

1 on FDA's record

K060336 — NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002Orthosoft, Inc.·cleared 2006-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Reason for recall

ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

Data sourced from openFDA. This site is unofficial and independent of the FDA.