_Incident · Recall_

# Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking

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

- **Occurred:** 2023-03-10
- **Kind:** `recall`
- **Status (derived):** active
- **Company:** [Stryker](/companies/stryker.md) (id: `661fbd42-9fcb-4d47-8a74-7a23d161d57b`)

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.

## Sources (0)

_No sources on file._

## 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.


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