Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA device recall Z-2075-2017 · posted 2017-05-12 · Terminated
Recall details
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- 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.
- Action taken
- This is a retrospective report of a correction taken on 20 June 2008. The two software issues were corrected in the new software version 2.2.1.3. There were 164 copies of the affected software, 5 of which were only temporary licenses. There were 152 of the 159 software copies that had a full license that were confirmed to have installed the updated instructions per the correction notice for a total percentage of 96%. All sales representatives were made aware of the software issues by written notice. Both software issues were corrected in a new revision of the software with no remaining effect. There have been no complaints since the correction was implemented. Recall notices were e-mailed to customers dated 06/20/2008.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 152
- Distribution
- 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, Aus
- Date initiated
- 2008-06-20
- Date posted
- 2017-05-12
- Date terminated
- 2017-05-15
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 (K060336) | Orthosoft, Inc. | 2006-04-28 |