Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA)
Brand(s)
Last updated
Summary
Product
Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| TKA 2.0 + TKA1.0.1+ THA 4.1. + PKA 3.0.2 + MGO 1.2.2 | Not applicable. | 700001590414 |
| TKA 2.0 + TKA1.0.1+ THA 4.0.0.1 + PKA 3.0.2 + MGO 1.2.2 | Not applicable. | 700001590415 |
Issue
Stryker discovered specific to the applications listed above, 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).
Recall start date: August 18, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Mako Surgical Corp.
3365 Enterprise Avenue, Weston, Florida, United States, 33331
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77996
Get notified
Receive notifications for new and updated recalls and alerts by category.