Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts
[RECALL]Aug 7, 2024 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
RECALL
Event Date
Aug 7, 2024
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Stryker recalled the Mako Integrated Cutting System (MICS) Handpiece over a saw-blade characterization error that could cause bone-preparation discrepancies. Distinct from the 2020 MICS checkpoint-verification recall already recorded. 897 units. Source: FDA Class 2 device recall Z-0044-2025, accessdata.fda.gov / openFDA enforcement.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
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
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
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Details
Incident Context & FAQ
What happened in Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts?
Stryker recalled the Mako Integrated Cutting System (MICS) Handpiece over a saw-blade characterization error that could cause bone-preparation discrepancies. Distinct from the 2020 MICS checkpoint-verification recall already recorded. 897 units. Source: FDA Class 2 device recall Z-0044-2025, accessdata.fda.gov / openFDA enforcement.
When did this incident occur?
The incident is recorded as occurring on August 7, 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 recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can 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 MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.