FDAFDA · Food and drugs·Recall number Z-0610-2017
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
Published November 23, 2016 · Recall initiated: October 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect lot number on outer kit
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- OMNI LIFE SCIENCE
- Distributor
- Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
- Lot
- Lot number: 19-09-021
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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