FDA Device recall Z-0610-2017
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during…
- FDA Device
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during… by Omni Life Science, citing incorrect lot number on outer kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0610-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-14 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Omni Life Science |
| Distribution | MD, OK, TX |
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
Identifiers
| code_info | Lot number: 19-09-021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0610-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.