Z-2075-2017 Class III Terminated
FDA device recall Z-2075-2017 was initiated by Orthosoft, Inc. dba Zimmer CAS on June 20, 2008 and is designated Class III. 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. The recall status is terminated (terminated May 15, 2017). Affected quantity: 152.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- June 20, 2008
- Termination Date
- May 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152
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.
Distribution Pattern
Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
Code Information
Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82