Robotic Arm Interactive Orthopedic System (RIO)
FDA device recall Z-1508-2016 · posted 2016-04-18 · Terminated
Recall details
- Recalling firm
- Mako Surgical Corporation
- Reason for recall
- Revision of the field manual
- Action taken
- As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 249
- Distribution
- Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
- Date initiated
- 2014-04-30
- Date posted
- 2016-04-18
- Date terminated
- 2019-07-24
- Location
- Plantation, FL
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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 |