Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking
[RECALL]Mar 10, 2023 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
RECALL
Event Date
Mar 10, 2023
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Certain lots of the Mako Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials, used in robotic partial knee arthroplasty, carried incorrect size laser marking, creating a wrong-size component risk. Source: FDA Class 2 device recall Z-1386-2023 (102 units in commerce), 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 Restoris MCK tibial baseplate trials over incorrect size laser marking?
Certain lots of the Mako Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials, used in robotic partial knee arthroplasty, carried incorrect size laser marking, creating a wrong-size component risk. Source: FDA Class 2 device recall Z-1386-2023 (102 units in commerce), accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on March 10, 2023 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 Restoris MCK tibial baseplate trials over incorrect size laser marking?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking?
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 Restoris MCK tibial baseplate trials over incorrect size laser marking?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.