# FDA recall Z-0408-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-11-29.

## Product

smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116    Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

## Reason for recall

One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

## Distribution

US Distribution to the state of OR, and Internationally to  Colombia.

## Key facts

- **Recall number:** Z-0408-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-01-31
- **Termination date:** 2020-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2018

## Citation

> AI Analytics. FDA recall Z-0408-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0408-2018. Source: US FDA. Licensed CC0.

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