Recall Z-1717-2019 ยท OLO Orthopedic Stereotaxic Instrument
OMNIlife science Inc.
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 facili
| Date | Apr 12, 2019 |
| Status | Terminated |
| Reason | The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. |
| Root cause | Under Investigation by firm |
| Action | On April 12, 2019, the firm notified customers of the recall through phone, email, and federal mailing titled URGENT MEDICAL DEVICE ADVISORY NOTICE. Customers were informed that the locking mechanism on the iBlock Cutting Guide may loosen during use. Customers were asked to: -Immediately quarantine lot MI1218 -Return product to the firm -Acknowledge receipt of the notice be completing and returning the Receipt form by fax or email. The firm's investigation is ongoing. For further information contact Christina Rovaldi, Sr. Regulatory Affairs Specialist at 774- 226-1847 or 800-448-6664. Co |
| Quantity | 9 |
| Distribution | US Nationwide distribution in the states of OK, SC, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090953 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK Praxim Medivision, SA, Jan 21, 2010 |