FDAFDA · Food and drugs·Recall number Z-1717-2019
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, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.
Published June 12, 2019 · Recall initiated: April 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- OMNIlife science Inc.
- Distributor
- US Nationwide distribution in the states of OK, SC, and WI.
- Lot
- MI1218
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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