OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is inten

FDA device recall Z-0610-2017 · posted 2016-11-17 · Terminated

Recall details

Recalling firm

OMNI LIFE SCIENCE

Reason for recall

Incorrect lot number on outer kit

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

OLO

Quantity affected

15 units

Distribution

Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.

Date initiated

2016-10-14

Date posted

2016-11-17

Date terminated

2017-02-01

Location

Raynham, MA

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