Z-1910-2024Class II

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total...

Name: Z-1910-2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total...
Creator: Stryker Orthopaedics
Published: 2024-04-15
License: https://open.fda.gov/license/

Stryker Orthopaedics / initiated 2024-04-15 / Open, Classified / root cause: design

FDA source

Stryker Orthopaedics began a recall of 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... on 2024-04-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1910-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-15
Posted: 2024-05-28
Recalling firm: Stryker Orthopaedics
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
Product code: OLO Orthopedic Stereotaxic Instrument
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
Root cause tag: design
FDA root 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: 334 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
Product codes and lots: UDI-DI: (01)7613327566468(10). Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2. Application Part Number: 700001590415. Revisions: AA, AB, AC, & AD.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1910-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1910-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28
Z-1911-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28
Z-1912-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28
Z-1913-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28
Z-1914-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28
Z-1915-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28

Product code OLO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)