Company: Stryker Orthopaedics
Date of Enforcement Report: 5/28/2024
Class II

PRODUCT

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

Recall Number:

Z-1910-2024

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.

RECALLING FIRM/MANUFACTURER:

Stryker Orthopaedics

VOLUME OF PRODUCT IN COMMERCE:

334 units

DISTRIBUTION:

Worldwide – US Nationwide and the countries of Australia, Canada, Chile, China, Columbia, India, Japan, Korea, Malaysia, Mexico, Sweden, Singapore, Thailand, and Netherlands.