# FDA recall Z-1778-2022

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2022-08-24.

## Product

Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

## Reason for recall

A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ.  However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

## Distribution

Distributed to one customer located in New York.

## Key facts

- **Recall number:** Z-1778-2022
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-24
- **Report date:** 2022-10-05

- **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-1778-2022

## Citation

> AI Analytics. FDA recall Z-1778-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1778-2022. Source: US FDA. Licensed CC0.

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