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Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty… recallZ-1913-2024 · Stryker Orthopaedics · initiated Apr 15, 2024

Class II Open, Classified All recalls posted in May 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Orthopaedics or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1913-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 15, 2024
Posted by the FDA
May 28, 2024
Recalling firm
Stryker Orthopaedics
Quantity
68 units
Product code
OLO
FDA submissions
K172301, K193515, K220459
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 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.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01

Code information (models, lots, serial numbers)

UDI-DI: (01)07613327629118(10). Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01. Revision: AA & AB.

Other devices under the same FDA submission

1 device cleared under K172301, K193515, K220459 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94473).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page