The RIO — Class II medical device recall Z-0385-2013
Terminated recall by Mako Surgical Corporation, reported 2012-11-28, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 t
| Recall number | Z-0385-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Plantation, FL, United States |
| Recall initiated | 2012-09-12 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-05-22 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | GB, HK, IT, JP, KR, SG, TR |
| Quantity | 137 devices |
| Reason classes | software |
| Model numbers | 204000 |
Product
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The 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 RIO is indicated for use in surgical knee and hip 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 (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.