Z-0610-2017 Class III Terminated
FDA device recall Z-0610-2017 was initiated by OMNI LIFE SCIENCE on October 14, 2016 and is designated Class III. Reason for recall: Incorrect lot number on outer kit The recall status is terminated (terminated February 1, 2017). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2016
- Initiation Date
- October 14, 2016
- Termination Date
- February 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
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
Reason for Recall
Incorrect lot number on outer kit
Distribution Pattern
Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
Code Information
Lot number: 19-09-021