| Date Initiated by Firm | October 14, 2016 |
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| Date Posted | November 17, 2016 |
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| Recall Status1 |
Terminated 3 on February 01, 2017 |
| Recall Number | Z-0610-2017 |
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| Recall Event ID |
75499 |
| 510(K)Number | K090953 |
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| Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
|
| Product | 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 |
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| Code Information |
Lot number: 19-09-021 |
Recalling Firm/
Manufacturer |
OMNI LIFE SCIENCE
480 Paramount Dr
Raynham MA 02767-1085
|
Manufacturer Reason
for Recall | Incorrect lot number on outer kit |
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FDA Determined
Cause 2 | Error in labeling |
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| 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 product, it does not affect other lots; and complete and return the Acknowledgement and Receipt Form and accompanying FN-102 by Fax to 508-519-3390.
Accounts are to hold item RM-10000 with the lot # 19-09-021 until a corrected label is provided for the outer box. The patient labels inside the box are correct.
For further information , Regulatory Affairs Specialist at 774-226-1847 or 800-448-6664 Monday through Friday, 8:00 AM to 4:30 PM, Easter Time. |
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| Quantity in Commerce | 15 units |
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| Distribution | Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = OLO
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