Recall Z-0610-2017— OMNI LIFE SCIENCE
Class III · Terminated
Class III FDA medical device recall by OMNI LIFE SCIENCE, initiated 2016-10-14, terminated 2017-02-01. It names one FDA 510(k) clearance: K090953. 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. Reason: Incorrect lot number on outer kit.
- Recalling firm
- OMNI LIFE SCIENCE
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-10-14
- Terminated
- 2017-02-01
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.