Stryker Orthopaedics: Device Recall
Recall #Z-1913-2024 · 04/15/2024
Recall Details
- Recall Number
- Z-1913-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Stryker Orthopaedics
- Status
- Ongoing
- Date Initiated
- 04/15/2024
- Location
- Montclair, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 units
Reason for Recall
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
Product Description
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.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
Distribution Pattern
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, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
Other Recalls by Stryker Orthopaedics
- Class II: Risk 04/15/2024
- Class II: Risk 04/15/2024