Home/Recalls/FDA Device/2021/Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee pr

FDA Device January 17, 2021

Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee pr

Hazard

Out of tolerance.

What You Should Do

Remedy

Stryker sent an Urgent Medical Device Removal letter dated May 14, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-855-741-4992 or email to strykerortho7035@stericycle.com.

Affected by this recall?