Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA device recall Z-2076-2017 · 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 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 .
- Action taken
- This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 153
- Distribution
- Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Z
- Date initiated
- 2008-10-28
- 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 |