Reported Jun 5, 2024 · Ongoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip…
Stryker Orthopaedics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Orthopaedics · 325 Mahwah · Montclair, NJ · 07043
Is this the product you have?
Total Knee Arthroplasty (TKA) 2Total Knee Arthroplasty (TKA) 1Partial Knee Arthroplasty (PKA) 3Total Hip Arthroplasty (THA) 4.04.1 on Mako 3.03.1
- SoftwareTKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it
- Application Part Number700002190743-01
- Lot codes and dates
- UDI-DI(01)07613327629118(10)
- SoftwareTKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it
- Application Part Number700002190743-01
- RevisionAA & AB
- Amount recalled
- 68 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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