Reported May 24, 2017 · Terminated
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthosoft, Inc. dba Zimmer CAS · 75 Queen St #3300 · Montreal · N/A
Is this the product you have?
- Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
- Lot codes and dates
- Product NameOrthosoft Universal TKR (software
- application) Product NumberORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
- Amount recalled
- 152
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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