Stryker Mako bone-registration accuracy recall (Class II, 2022)
[RECALL]Jul 1, 2022 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
RECALL
Event Date
Jul 1, 2022
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).
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
Related Incidents & Failure Precedents
6 records on file- Zoox recalls entire 105-vehicle fleet after robotaxi drove into smoke-filled active fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Phoenix
Details - Zoox recalls entire 105-vehicle fleet because robotaxis may not detect heavy smoke and could impede emergency responders[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis after vehicle drove into heavy smoke at active Las Vegas fire scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox issues software recall after robotaxi drove through heavy smoke at Las Vegas emergency scene[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox recalls 105 robotaxis over failure to detect heavy smoke (NHTSA 26E044)[RECALL]
Jul 17, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Waymo recalls nearly 3,800 robotaxis over freeway construction zone risks[RECALL]
Jun 30, 2026 · Waymo · Waymo Driver (6th gen) · Sacramento, California, USA
Details
Incident Context & FAQ
What happened in Stryker Mako bone-registration accuracy recall (Class II, 2022)?
Stryker issued a voluntary field safety corrective action for the Mako SmartRobotics system relating to potential bone surface registration inaccuracies under specific intraoperative conditions. Affected units received software update. FDA classified as Class II recall. Filed in FDA enforcement reports as recall Z-0512-2023 (initiated 2022).
When did this incident occur?
The incident is recorded as occurring on July 1, 2022 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 bone-registration accuracy recall (Class II, 2022)?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker Mako bone-registration accuracy recall (Class II, 2022)?
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 bone-registration accuracy recall (Class II, 2022)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.