Recall Z-0610-2017 ยท OLO Orthopedic Stereotaxic Instrument
OMNI LIFE SCIENCE
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
| Date | Nov 17, 2016 (initiated Oct 14, 2016) |
| Status | Terminated |
| Reason | Incorrect lot number on outer kit |
| Root cause | Error in labeling |
| Action | The firm, OMNIlife Science, Inc., issued an "URGENT MEDICAL DEVICE ADVISORY NOTICE" dated 10/14/16 by email to its consignees/customers. U.S. and foreign agents were also sent the notification packet via overnight mail. Acknowledgement of receipt is requested. The notice described the product, problem and actions to be taken. The customers were instructed to immediately quarantine lot 19-09-021 for OMNIBotics Tracker Kit RM-1000; overlabel the outside packaging with the label provided following the provided training paperwork and rework instructions; note advisory notice only includes listed |
| Quantity | 15 units |
| Distribution | Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090953 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK Praxim Medivision, SA, Jan 21, 2010 |