# FDA recall Z-0396-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-12-11.

## Product

smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R     Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) 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

Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

## Distribution

US Distribution to states of: MI, GA, and OH.

## Key facts

- **Recall number:** Z-0396-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-11
- **Report date:** 2018-01-31
- **Termination date:** 2018-06-22

- **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-0396-2018

## Citation

> AI Analytics. FDA recall Z-0396-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0396-2018. Source: US FDA. Licensed CC0.

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