Stryker Orthopaedics 2024-06-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1913-2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee… Recall
Issued June 5, 2024 · Stryker Orthopaedics
In June 2024, Stryker Orthopaedics recalled the Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Orthopaedics to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Stryker Orthopaedics
- Category
- Health
- Recall date
- June 5, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Finland, France, German
- Recall number
- FDA-Z-1913-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Orthopaedics has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.