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Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts

A characterization issue with the Mako MICS Handpiece (mounted on the distal end of the Mako robotic arm for bone preparation in total and partial knee procedures) could cause unsuccessful checkpoint verification of the saw blade and a discrepancy during bone preparation, so the surgeon could make cuts differing from the preoperative plan. Distinct from the 2024 Mako Total Knee software 'error #3' recall. Source: FDA Class 2 device recall Z-0472-2021, accessdata.fda.gov.

Occurred 2020-10-23 · Stryker · Investigated by FDA

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Track Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Stryker&productdescriptiontxt=Mako&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100

Common questions

What happened in Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts?
A characterization issue with the Mako MICS Handpiece (mounted on the distal end of the Mako robotic arm for bone preparation in total and partial knee procedures) could cause unsuccessful checkpoint verification of the saw blade and a discrepancy during bone preparation, so the surgeon could make cuts differing from the preoperative plan. Distinct from the 2024 Mako Total Knee software 'error #3' recall. Source: FDA Class 2 device recall Z-0472-2021, accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on October 23, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts?
The incident is recorded as involving Stryker on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts?
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 recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

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1
primary-fda-database
FDA database

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

Methodology surface for Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts.

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