Class 2 Device Recall Stryker Mako 3.0 and 3.1

• Date Initiated by Firm: April 15, 2024
• Date Posted: May 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1912-2024
• Recall Event ID: 94473
• 510(K)Number: K172301 K193515 K220459
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• 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.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
• Code Information: UDI-DI: (01)07613327629095(10). Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04. Revision: AA & AB.
• Recalling Firm/ Manufacturer: Stryker Orthopaedics; 325 Mahwah; Montclair NJ 07043
• Manufacturer 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
• FDA Determined 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 Robot Arm Utilities. Recommendations for patients included that patients should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Additional or more frequent patient monitoring or follow up may be required in accordance with clinical judgment. Consignees were instructed to inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware, utilize the provided risk mitigation steps to prevent the occurrence of software error #3 or to clear software error #3 if it is generated by the Mako Robotic System, complete and return the enclosed Urgent Medical Device Correction Business Reply Form. On about 08/15/2025, Stryker notified consignees, via letter, of an UPDATE to the initial notification to provide all impacted consignees with instructions for a software upgrade which will provide a permanent fix to the software issue.
• Quantity in Commerce: 20 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, Singapore, Spain, South Africa, Sweden, Switzerland, Thailand, Turkey, UAE, and UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO