International safety notice
Software de las aplicaciones implementadas en el sistema robótico Mako 3.0 y 3.1: Total Knee Arthroplasty (TKA) 1 y 2 Partial Knee Arthroplasty (PKA) 3 Total Hip Arthroplasty (THA) 4.0 y 4.1
Spain / AEMPS · ESP · Jun 7, 2024
Key facts
| Title | Software de las aplicaciones implementadas en el sistema robótico Mako 3.0 y 3.1: Total Knee Arthroplasty (TKA) 1 y 2 Partial Knee Arthroplasty (PKA) 3 Total Hip Arthroplasty (THA) 4.0 y 4.1 |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Software de las aplicaciones implementadas en el sistema robótico Mako 3.0 y 3.1: Total Knee Arthroplasty (TKA) 1 y 2 Partial Knee Arthroplasty (PKA) 3 Total Hip Arthroplasty (THA) 4.0 y 4.1 |
| Manufacturer | Stryker Joint Replacement, EEUU. |
| Models | 700002190743-04, 700002190743-05, 700001590414, 07613327629095, PKA3.0.2.FR, PKA3.0.2.IT, 209999, 1.0.1, RA2024-3598242, 1.0.1.FR.1, 700002190743-01, 91.822.52.89 and 27 more |
| Event type | Safety Notice |
| Date | Jun 7, 2024 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1