OMNIBotics Tracker Kit Recalled for Incorrect Lot Number Labeling
OMNI Life Science is recalling 15 OMNIBotics Tracker Kits due to incorrect lot numbers on the outer packaging.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a documentation/packaging error (incorrect lot number) rather than a functional defect or contamination, which aligns with the 'Low' severity criteria for packaging-only problems.
Plain-English summary
OMNI Life Science is recalling 15 units of the OMNIBotics Tracker Kit, Model RM-10000, due to an incorrect lot number printed on the outer kit packaging. The product is a navigation system intended for use during stereotaxic surgery, specifically for Total Knee Arthroplasty, to aid surgeons in locating anatomical structures and aligning endoprostheses.
The affected units are identified by Lot number 19-09-021. The recall covers units distributed in the United States to Oklahoma, Maryland, and Texas, as well as in Australia. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and consumers who have this specific product should stop using it and contact OMNI Life Science for instructions on return or replacement.
The recalled product
- 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.…
- Manufacturer
- OMNI LIFE SCIENCE
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 19-09-021
Distribution
Related recalls
Same manufacturer · OMNI LIFE SCIENCE
See all →- HighOmni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
FDA (Devices) · 2012-09-19
- HighOmni Life Science Apex Knee System Modular Tibia Augment Recall
FDA (Devices) · 2012-09-19
- HighOmni Life Science Recalls Apex Knee System Modular Tibia Augments
FDA (Devices) · 2012-09-19
- SevereOmni Life Science Recalls Apex Knee System Modular Tibia Augments
FDA (Devices) · 2012-09-19
- HighOmni Life Science Recalls Apex Knee System Tibia Augments
FDA (Devices) · 2012-09-19
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- HighOMNIBotics iBlock Cutting Guide Recalled for Failure to Lock During Surgery
FDA (Devices) · 2019-06-12
- HighOmnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings
FDA (Devices) · 2015-09-02
- ModerateOMNI Hip System Acetabular Inserts Recalled for Improper Labeling
FDA (Devices) · 2018-08-01
- ModerateZimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash
FDA (Devices) · 2017-05-03
- ModerateZimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
FDA (Devices) · 2017-05-24
- ModerateConformis Recalls Two iTotal CR Total Knee Replacement Systems
FDA (Devices) · 2019-04-17