Z-2794-2018 Class II Terminated
FDA device recall Z-2794-2018 was initiated by Mako Surgical Corporation on May 10, 2018 and is designated Class II. Reason for recall: Out of tolerance. The recall status is terminated (terminated January 17, 2021). Affected quantity: 10,606.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- May 10, 2018
- Termination Date
- January 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,606
Product Description
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 procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
Reason for Recall
Out of tolerance.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom
Code Information
Lots #'s: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.