Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 5, 2024
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
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…
Stryker Orthopaedics recalled Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthropla… - a moderate-severity action.
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthropla… was recalled by Stryker Orthopaedics in June 5, 2024. Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 21999…. Check the official notice for the remedy. Verify recall #Z-1913-2024 with the FDA Devices before acting.
The recall
Stryker Orthopaedics issued this moderate-severity FDA Devices recall-Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 21999….
- Moderate
- severity level
- 68 units
- affected scope
- Class II
- classification
- June 5, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1913-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1913-2024) was formally reported on June 5, 2024, with the manufacturer initiating the action on April 15, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Orthopaedics is listed as the recalling firm, operating out of Montclair, NJ. Federal records list the affected scope as 68 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Me…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
68 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1913-2024 |
| Date reported | June 5, 2024 |
| Date initiated | April 15, 2024 |
| Recalling firm | Stryker Orthopaedics |
| Firm location | Montclair, NJ |
| Affected scope | 68 units |
| 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, N… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1913-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Orthopaedics. Units affected: 68 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1913-2024.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1913-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 5, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.