Recall MonitorHealth Products
Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
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
Recall class: Type II
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