Device 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
Z-0610-2017
Product summary
- Event
- Event 75499
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0610-2017
Official wording
Reason: Incorrect lot number on outer kit
Code information: Lot number: 19-09-021
Distribution pattern: Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
Derived failure modes
-
Unknown
Incorrect lot number on outer kit