DEPLOYDatabase

Incident · Recall

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.

Occurred 2023-03-10 · Stryker · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking

Machine-readable surfaces

Sources (1)

  1. 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

Common questions

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.
Who was involved in Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking?
The incident is recorded as involving Stryker on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
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.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

Canonical ID 1ad4d4b8-1b96-4979-b7b4-840e4b0bc0cf