Z-1911-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,635 units
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 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
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
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
Code Information
UDI-DI: (01)7613327566444(10). Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2. Application Part Number: 700001590414. Revision: AA, AB, & AC.