Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO),
FDA device recall Z-1128-2015 · posted 2015-02-19 · Terminated
Recall details
- Recalling firm
- Mako Surgical Corporation
- Reason for recall
- When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
- Action taken
- On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 228 units
- Distribution
- Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and H
- Date initiated
- 2015-01-22
- Date posted
- 2015-02-19
- Date terminated
- 2016-12-14
- Location
- Plantation, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM (K112507) | Mako Surgical Corporation | 2012-03-01 |