Z-1717-2019 Class II Terminated
FDA device recall Z-1717-2019 was initiated by OMNIlife science Inc. on April 12, 2019 and is designated Class II. Reason for recall: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. The recall status is terminated (terminated May 14, 2020). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 12, 2019
- Termination Date
- May 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
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.
Reason for Recall
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Distribution Pattern
US Nationwide distribution in the states of OK, SC, and WI.
Code Information
MI1218