OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS… — Class III medical device recall Z-0610-2017
Terminated recall by OMNI LIFE SCIENCE, reported 2016-11-23, distributed in MD, OK, TX. Incorrect lot number on outer kit
| Recall number | Z-0610-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMNI LIFE SCIENCE, Raynham, MA, United States |
| Recall initiated | 2016-10-14 |
| Classified | 2016-11-17 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-02-01 |
| Distributed | MD, OK, TX |
| Countries outside the US | AU |
| Quantity | 15 units |
| Reason classes | labeling |
| Lot numbers | 19-09-021 |
| Model numbers | RM-10000 |
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 for recall
Incorrect lot number on outer kit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0610-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.