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Incident · Recall

Stryker Mako Total Knee software correction over 'error #3' codes when switching applications

Voluntary software correction (announced ~May 28 2024; Class 2): increased 'software error #3' codes when switching between the total-knee and total-hip applications without a shutdown/restart, risking loss/deterioration of robotic function, surgical delay, or conversion to manual. Mitigation = shutdown/restart before switching apps. Cap-flag: exact units/Z-number not captured; other Mako accessory Class-2 recalls exist (handpiece, tracking kits, saw attachment) not individually verified here.

Occurred 2024-05-28 · Stryker Mako SmartRobotics at Global · Stryker · Global · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Outcomes (1)

  • regulatory actionverified

Revision history (1)

  • 2026-06-05 · outcome_class

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (1)

  1. MassDevice · https://www.massdevice.com/stryker-warns-software-error-mako-surgical-robot/

Common questions

What happened in Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
Voluntary software correction (announced ~May 28 2024; Class 2): increased 'software error #3' codes when switching between the total-knee and total-hip applications without a shutdown/restart, risking loss/deterioration of robotic function, surgical delay, or conversion to manual. Mitigation = shutdown/restart before switching apps. Cap-flag: exact units/Z-number not captured; other Mako accessory Class-2 recalls exist (handpiece, tracking kits, saw attachment) not individually verified here.
When did this incident occur?
The incident is recorded as occurring on May 28, 2024 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Stryker Mako Total Knee software correction over 'error #3' codes when switching applications?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-07-21

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stryker Mako Total Knee software correction over 'error #3' codes when switching applications.

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Canonical ID 481430cf-9415-451a-b2b0-00f582214f99