The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing softwar
FDA device recall Z-0385-2013 · posted 2012-11-19 · Terminated
Recall details
- Recalling firm
- Mako Surgical Corporation
- Reason for recall
- MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
- Action taken
- Mako Surgical Corporation sent an Important Medical Device Correction letter dated August 31, 2012, to all affected customers. The letter included specifics regarding the software issue and how the correction will take place. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them to establish the appropriate time for the upgrade .Customers were asked to return by fax an Acknowledgement Form to 954-927-0446, ATTN: Quality Assurance. For questions customers were instructed to call 954-628-0447. For questions regarding this recall call 954-927-2044, ext 605.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 137 devices
- Distribution
- Worldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Jap
- Date initiated
- 2012-09-12
- Date posted
- 2012-11-19
- Date terminated
- 2013-05-22
- Location
- Plantation, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 (K081867) | Mako Surgical Corp. | 2008-11-25 |