Answer

What incidents have involved Stryker Mako SmartRobotics?

Q: What incidents have involved Stryker Mako SmartRobotics?

As of 2026-08-25, the DEPLOY registry records 9 tracked incident(s) involving Stryker Mako SmartRobotics. Severity distribution: 0 catastrophic, 0 critical, 7 serious, 2 moderate, 0 minor.

Every tracked incident involving Stryker Mako SmartRobotics from Stryker. As of 2026-08-25, 9 tracked incidents on record.

7 serious2 moderate

Every incident, most recent first

Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)
seriousmalfunctionFDA (MAUDE)none
2025-04-01
Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)
seriousmalfunctionFDA (MAUDE)none
2024-08-15
Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts
seriousrecallFDArecall ordered
2024-08-07
Stryker Mako Total Knee software correction over 'error #3' codes when switching applications
moderaterecallFDArecall ordered
2024-05-28
Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking
moderaterecallFDArecall ordered
2023-03-10
Stryker Mako bone-registration accuracy recall (Class II, 2022)
seriousrecall
2022-07-01
Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)
seriousinjuryFDA (MAUDE)none
2020-11-11
Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts
seriousrecallFDArecall ordered
2020-10-23
Stryker recalls Mako RIO over loss of system power mid-procedure
seriousrecallFDArecall ordered
2017-06-07

Rebuilt every 15 minutes. Filter: incidents.model_id = Stryker Mako SmartRobotics. Severity ladder: catastrophic, critical, serious, moderate, minor. Kind is orthogonal to severity (collision, recall, malfunction, injury, fatality, and others). This page renders only for models with 3 or more tracked incidents; thinner records 404 rather than surface a one-off. See the full Stryker Mako SmartRobotics record for specs, deployments, and supply chain.