Recall Z-1881-2017— Orthosoft, Inc. dba Zimmer CAS
Class II · Terminated
Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2011-10-06, terminated 2017-05-08. It names one FDA 510(k) clearance: K110054. Product: Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components. Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash..
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-10-06
- Terminated
- 2017-05-08
- Firm location
- Montreal, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-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 CAS Software application intended to assist in the placement of total knee replacement components
Reason for recall
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Data sourced from openFDA. This site is unofficial and independent of the FDA.