FDA Device recall Z-1411-2017
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery
- FDA Device
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery by Mako Surgical, citing five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1411-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-22 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | US |
Product
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reason
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Identifiers
| code_info | Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #…Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2017%22
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