FDAApril 12, 2019device
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
What to do
FDA enforcement status: Terminated
Brands named
omnilife scienceomnilife
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD2025-07-08
- FDABD Trucount Controls, 30 Test - REF: 3403352025-07-08
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