Use cautionMedical device recall · FDA · Published April 12, 2019
OMNIBotics iBlock Cutting Guide Recall: May loosen during use
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.
“OMNIBotics iBlock Cutting Guide Recall: May loosen during use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68342-omnibotics-iblock-cutting-guide-recall-may-loosen-during-use. Based on FDA recall #Z-1717-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1717-2019%22&limit=1).
OMNIlife science Inc. recalled the OMNIBotics iBlock Cutting Guide, model 4146-1000, because it may loosen during use, according to the FDA on April 12, 2019.
How to tell if you have it
Brand: OMNIlife
Product: OMNIBotics iBlock Cutting Guide
Model: 4146-1000
The hazard
The stainless-steel surgical instrument does not lock onto the iBlock Saw Guide as intended and may loosen during use, according to the FDA.
Context
GovInfoNow's records show OMNIlife science Inc. has issued six other recalls since November 20, 2017. Other recent recalls of similar products include the OMNI Hip System Model HC-00070 (September 11, 2019) and the OMNIl: ApeX Acetabular Liner Hip Prosthesis (July 23, 2019).
How to tell if you have this one
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.
Brand
OMNIlife
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Loose Attachment
Ensure the cutting guide is securely locked to the iBlock Saw Guide before use during surgery.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of OK, SC, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Oklahoma, South Carolina, Wisconsin.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1717-2019 (April 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1717-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.