Recall Z-2076-2017— Orthosoft, Inc. dba Zimmer CAS
Class II · Terminated
Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2008-10-28, terminated 2017-05-15. It names one FDA 510(k) clearance: K060336. Product: Navitrack System - OS Knee Universal, Stereotaxic instrument. Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies ..
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-10-28
- Terminated
- 2017-05-15
- Firm location
- Montreal, 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, Stereotaxic instrument
Reason for recall
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
Data sourced from openFDA. This site is unofficial and independent of the FDA.