# FDA recall Z-1385-2023

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2023-03-10.

## Product

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

## Reason for recall

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

## Distribution

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

## Key facts

- **Recall number:** Z-1385-2023
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2023

## Citation

> AI Analytics. FDA recall Z-1385-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1385-2023. Source: US FDA. Licensed CC0.

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