---
title: "stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende... — FDA record Z-1385-2023 | Is It on Recall"
description: "Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking"
url: https://isitonrecall.com/recall/fda-device-z-1385-2023-stryker-mako-restoris-mck-baseplate-trial-size-5-rm-ll-ref-170615-intended-for-use-in-a-partial-knee/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty... — FDA record Z-1385-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
- **Reason**: Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- **Classification**: Class II
- **Recalling firm**: Howmedica Osteonics Corp.
- **Quantity**: 52 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1385-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1385-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GTIN 00848486003746, Lot Number 26270421 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S., Netherlands, Japan, China, India, Korea, and Australia.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 19, 2023
- **Recall initiation date**: Mar 10, 2023
- **Center classification date**: Apr 12, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1385-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Howmedica Osteonics Corp. records](https://isitonrecall.com/brand/howmedica-osteonics-corp/)