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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Mako 3.0 and 3.1

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 Class 2 Device Recall Stryker Mako 3.0 and 3.1see related information
Date Initiated by FirmApril 15, 2024
Date PostedMay 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1910-2024
Recall Event ID 94473
510(K)NumberK172301 K193515 K220459 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductTotal 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
Code Information UDI-DI: (01)7613327566468(10)
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 2
Device Design
ActionStryker issued Urgent Medical Device Correction Letter (PFA 3396511) issued by third party Sedgwick on April 15, 2024. Letter states reason for recall, health risk and action to take: Risk Mitigation: " 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. " 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 patient: 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. Actions Needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Utilize the above 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. 3. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form and email to strykerortho5868@sedgwick.com/ fax (866) 342-1029. 4. Please contact your Local Sales Office or your Stryker Sales Representative directly for assistance. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For qu
Quantity in Commerce334 units
DistributionWorldwide - US Nationwide and the countries of Australia, Canada, Chile, China, Columbia, India, Japan, Korea, Malaysia, Mexico, Sweden, Singapore, Thailand, and Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OLO
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