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.
What this means for you
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
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