Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated
FDA device recall Z-0224-2016 · posted 2015-11-05 · Terminated
Recall details
- Recalling firm
- Mako Surgical Corporation
- Reason for recall
- The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
- Action taken
- As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 1,322 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, W
- Date initiated
- 2015-07-16
- Date posted
- 2015-11-05
- Date terminated
- 2016-12-14
- Location
- Plantation, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM (K121064) | Mako Surgical Corporation | 2012-06-06 |
| RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM (K112507) | Mako Surgical Corporation | 2012-03-01 |