Navitrack¿ System - OS Knee Universal recall: Software Issue
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Why was Navitrack¿ System - OS Knee Universal recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
- Product
- Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Quantity
- 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, Austria, France, Italy, Singapore, United Kingdom
- Recall date
- May 24, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)