Device product
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Z-1411-2017
Product summary
- Event
- Event 76158
- Status
- Terminated
- Classification
- Class II
- Quantity
- 777
- Official record key
device-enforcement:Z-1411-2017
Official wording
Reason: Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Code information: 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
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides