# FDA recall Z-1913-2024

> **Stryker Orthopaedics** · Class II · device recall initiated 2024-04-15.

## Product

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

## Reason for recall

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

## 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

## Key facts

- **Recall number:** Z-1913-2024
- **Recalling firm:** Stryker Orthopaedics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-15
- **Report date:** 2024-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montclair, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2024

## Citation

> AI Analytics. FDA recall Z-1913-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1913-2024. Source: US FDA. Licensed CC0.

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