Recall Z-1717-2019— OMNIlife science Inc.
Class II · Terminated
Class II FDA medical device recall by OMNIlife science Inc., initiated 2019-04-12, terminated 2020-05-14. It names one FDA 510(k) clearance: K090953. 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 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: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use..
- Recalling firm
- OMNIlife science Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-12
- Terminated
- 2020-05-14
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.