Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts
[RECALL]Oct 23, 2020 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
RECALL
Event Date
Oct 23, 2020
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
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 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.
What robot was involved in Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could 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 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.