Reported Nov 23, 2016 · Terminated
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is…
Omni Life Science
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: OMNI LIFE SCIENCE · 480 Paramount Dr · Raynham, MA · 02767-1085
Is this the product you have?
- OMNIBotics Tracker Kit -ModelRM-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 forTotal Knee Arthroplasty
- Lot codes and dates
- Lot number19-09-021
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
Incorrect lot number on outer kit
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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