OMNIlife recalls iBlock Cutting Guide 4146-1000 due to potential loosening during use. This surgical tool is used with robotic knee implants and may cause injury if not securely attached.
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
OMNIlife is recalling the OMNIBotics iBlock Cutting Guide (model 4146-1000) because it may loosen during use with the iBlock Saw Guide. This could lead to improper bone preparation and potential injury during knee replacement surgery.
The cutting guide may loosen during use, which could cause improper bone preparation. This might lead to complications during the knee replacement surgery if the guide isn't securely attached to the saw guide.
Surgical teams using the OMNIBotics iBlock Cutting Guide with the iBlock Saw Guide for total knee arthroplasty procedures are most at risk. Patients undergoing knee replacement surgery with this specific surgical system may be affected.
Check for the model number 4146-1000 on the OMNIBotics iBlock Cutting Guide. This surgical tool is used with the iBlock Saw Guide and OMNI Apex Knee System during total knee arthroplasty procedures.
Ensure the cutting guide is securely locked to the iBlock Saw Guide before use during surgery.
The recall indicates a potential risk of loosening during use, so it is not recommended for use without verification of secure attachment.
The recall does not specify a remedy, so users should check for secure attachment before use and contact OMNIlife for further guidance.
Yes, this cutting guide is used with the OMNI Apex Knee System during total knee arthroplasty procedures.
We’ve drafted a message you can send OMNIlife to request your refund or repair — edit it as you like.
Subject: Recall Z-1717-2019 — OMNIlife OMNIlife Hello, I own a OMNIlife that is covered by recall Z-1717-2019 from OMNIlife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
