OMNIBotics iBlock Cutting Guide Recalled for Failure to Lock During Surgery
OMNIlife science Inc. is recalling 9 OMNIBotics iBlock Cutting Guides because they may not lock onto the iBlock Saw Guide as intended and could loosen during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a surgical instrument that may loosen during use, presenting a risk of harm to patients during a procedure. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OMNIlife science Inc. is recalling 9 units of the OMNIBotics iBlock Cutting Guide, model 4146-1000. This stainless-steel surgical instrument is used during total knee arthroplasty in conjunction with the iBlock Saw Guide and the OMNIBot robotic Motor Unit to prepare bone for implantation of the OMNI Apex Knee System.
The recall was initiated because the iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. The affected units were distributed nationwide in the states of Oklahoma, South Carolina, and Wisconsin. The specific code for the affected units is MI1218.
Healthcare providers and consumers who have this product should stop using it immediately and contact OMNIlife science Inc. for further instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 9
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)
- MI1218
Distribution
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