Recall Z-1910-2024 ยท OLO Orthopedic Stereotaxic Instrument
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
| Date | May 28, 2024 (initiated Apr 15, 2024) |
| Status | Open, Classified |
| Reason | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment |
| Root cause | Device Design |
| Action | Stryker issued Urgent Medical Device Correction Letter (PFA 3396511) issued by third party Sedgwick on April 15, 2024. Consignees were instructed on the following Risk Mitigation steps: 1. System Restart: Once an application has been launched a Mako System shutdown or a Mako System restart prior to launching another application eliminates occurrence of the issue. 2. Restart Arm Software: Restarting the Mako Arm software prior to the start of a case or after the occurrence of Software Error 3 (SE3) eliminates occurrence of the issue. The Restart Arm Software option is accessible through the Rob |
| Quantity | 334 units |
| Distribution | Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Puerto Rico, Qatar, Romania, Saudi Arabia, Singap |
| FDA record | Open on fda.gov |