Field Safety Notice - 29 may to 2 June 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 29 May to 2 June 2017

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

Beckman Coulter: Synchron AQUA CAL Level 1

31 May 2017

IVDs, clinical chemistry

MHRA reference: 2017/006/001/601/002

Exactech: Logic Fit Tibial Tamp Head Instrument

23 May 2017

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2017/005/026/701/003

Exactech: Equinoxe Modular and Non-Modular Pilot Tip Reamers

23 May 2017 - 05232017-03

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2017/005/026/701/005

Exactech: Novation Calcar Planer Guide Tip

23 May 2017 - 05232017-02

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2017/005/026/701/004

Magellan: LeadCare/ LeadcareII/Leadcare Ultra/Leadcare Plus

24 May 2017

IVDs, clinical chemistry

Model: LeadCare/ LeadcareII/Leadcare Ultra/Leadcare Plus

MHRA reference: 2017/006/001/291/012

Roth: MOBELI Stabi Vario / MOBELI Dual Grip

01 June 2017

X-ray, general

Model: MOBELI Stabi Vario / MOBELI Dual Grip

MHRA reference: 2017/006/001/291/005

Sentinel: Creatinine (Enzymatic)

22 May 2017

IVDs, clinical chemistry

MHRA reference: 2017/006/001/291/011

TransMedics: OCS Heart

01 June 2017

Storage and collection devices

Model: 1200

MHRA reference: 2017/005/026/601/004

Zimmer: Werber Countersink Cannulated for micro CBS screw

23 May 2017

Osteosynthesis, bone screws

MHRA reference: 2017/005/031/701/012

Updates to this page

Published 7 June 2017